Andrew Southcott (Boothby, Liberal Party, Shadow Parliamentary Secretary for Primary Healthcare) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010 introduces a number of amendments to the Therapeutic Goods Act 1989. The coalition does not oppose the government’s regulatory reform plan designed to improve the regulation of therapeutic goods in Australia. At present the act covers short-term exemptions for medicines to serve as substitutes for other medicines that are on the Australian Register of Therapeutic Goods but which are unavailable or in short supply and medicines that have no substitute registered in Australia. This bill transfers the same arrangements to medical devices as apply for medicines currently.

Schedule 1 of the bill introduces mirroring provisions for medical devices. The amendments are intended to enable the Secretary to the Department of Health and Ageing to approve the importation and supply of certain medical devices in a number of circumstances. In particular, the amendments enable the secretary to grant approval for the importation and supply of medical devices that are not on the register to act as substitutes for devices that are on the register where these devices are in short supply or unavailable.

The other amendments are largely administrative. These include allowing the secretary to list export-only variations of medicines which are already included on the register; improving the capacity of the TGA to obtain information in relation to medicines; allowing the minister to determine lists of permissible ingredients to be included in medicines; and specifying that persons applying for reconsideration by the minister of an initial decision by the TGA must provide all the information they wish to be considered at the time of application. This bill was previously introduced earlier this year but lapsed with the prorogation of the parliament.

One issue that I should flag is that when the legislation was originally introduced, the Senate Standing Committee for the Scrutiny of Bills expressed concern about the way the bill had been drafted, particularly that proposed subsection 26BB(7), item 3 in schedule 2, provided for incorporating material by reference. The committee did state some concern about that in that it can lead to the ability for a change in obligations to be imposed without reference to the parliament. The committee did seek the minister’s advice about the justification for the way that this bill has been drafted and the opposition will be seeking a response to that. Having said that, we do not see this as a controversial bill. It is essentially about improving the regulation of the therapeutic goods in Australia under the Therapeutic Goods Act 1989. In discussions with stakeholders no concerns were raised about the amendments to this act. It was seen as being a sensible alignment with the way medicines are treated.

The amendments to the act are largely technical or administrative in nature. They do enhance the operation of the act and the efficiency of the TGA. They support Australian companies who wish to export medicines and they improve the TGA’s ability to obtain information from persons who have registered or listed medicines. The legislation also improves the TGA’s ability to obtain information on whether registered or listed medicines have been imported to Australia, supplied in Australia or exported from Australia. It also revises the process in which the minister can reconsider an initial decision by the TGA.

Speaking briefly on the TGA, I believe it is disappointing that the joint regulatory agency, which was planned with New Zealand, will now not be going ahead due to concerns at the New Zealand end, not the Australian end. That is disappointing. We have had a regulatory reform package which originally had in mind a joint regulator between Australia and New Zealand but now it would just be applying to Australia.

This bill will enable the TGA to continue to operate effectively and to keep up with other therapeutic goods regulators around the world and the opposition will not be opposing this legislation.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010 and the government amendments. At the outset of my contribution to this debate I would like to mention that, whilst this was introduced in the last parliament, I can actually see the fingerprints of the new Parliamentary Secretary for Health and Ageing, the member for Ballarat, on this as well. I know she has a long history working in this area and I know that parliament will benefit enormously from her experience prior to entering this parliament. Mr Speaker, I would like to—

Peter Slipper (Fisher, Liberal Party) Share this | Link to this | Hansard source

Thank you for the promotion.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

Any time! Mr Deputy Speaker, this legislation provides a statutory basis for the current practice of the secretary approving product information for prescription medicines as part of the registration process and, for the latter, variation of approved product information. It provides a clear statutory basis for the secretary to vary entries in the register for registered and listed goods, medical devices and biologicals, and to charge fees in relation to requests for such variations. Being a member of the Standing Committee on Health and Ageing for a number of years, I know how important that flexibility is.

This legislation supports the implementation of the business review process for prescription medicines by ensuring that the secretary can prescribe relevant documents and information that must be provided in applications for registration of prescription medicines and requests for variation of those entries. The time frames within which such documents and information is required reflects what has been agreed with the sponsor. The evaluation by the TGA of applications for registration of prescription medicines can continue even if an applicant has not provided all the documents and information requested during the evaluation by the secretary within the agreed time frames. It also ensures that the offence of failing to comply with a request from the secretary to provide information on documents does not apply to requests for application for registration or listings but only when a request is made to those who currently have goods on the register or who have had goods on the register in the previous five years. This corrects a drafting error.

The legislation also clarifies the power of the minister to determine what ingredients can be included in lists of medicines and the criteria that must be taken into account if a person requests a variation to the list of such ingredients. It also ensures that the secretary can determine that particular goods continue to be treated as therapeutic goods in appropriate cases even if a food standard is made when such goods or their status as a food or therapeutic good is otherwise not clear. There has been community consultation on this legislation. Similar legislation was introduced in the previous parliament. It is non-controversial legislation. It is legislation that will benefit the community as a whole and I commend the legislation to the House.

Ms Catherine King (Ballarat, Australian Labor Party, Parliamentary Secretary for Health and Ageing) Share this | Link to 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.