Brett Raguse (Forde, Australian Labor Party) Share this | Hansard source

I rise today to speak about the Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 and the Therapeutic Goods (Charges) Amendment Bill 2009. The Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 is the fourth in a series of bills to implement reforms to the regulation of therapeutic goods in Australia through amendments to the Therapeutic Goods Act 1989. The legislation reflects the government’s commitment to maintaining the position of Australia’s Therapeutic Goods Administration, the TGA, as a leading global regulator of therapeutic goods and to continue to strengthen and enhance this well-deserved position. It builds upon the other therapeutic goods reform bills approved by parliament over the past year, to further strengthen and improve Australia’s therapeutic goods regulatory framework. This legislation includes a new regulatory framework for cellular and tissue based therapy products, known as biologicals, so that these products can be regulated as a specific therapeutic goods group.

Implementation of the biologicals framework was agreed to in 2006 by the Australian Health Ministers’ Conference and was among other improvements that were to have been adopted as part of legislation underpinning the proposed Australia-New Zealand therapeutic products authority, ANZTPA. The Rudd government is committed to moving forward to implement these improvements. We have delivered on that commitment, with the majority of improvements now implemented through the reform bills that were passed by the parliament last year, in this current bill and in another just introduced amendment that is before the House today.

Schedule 1 of the Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 will implement a new framework for the regulation of biologicals and will bring Australia’s regulation of these products into line with other leading therapeutic goods regulators around the world including, importantly, the United States, Canada and the European Union. Biologicals include things such as skin tissue for use in grafts following burns, and bone for grafting. It is envisaged that a legislative instrument will be made under the biologicals framework to declare that organs donated for transplantation and assisted reproductive tissues such as IVF embryos will not be classified as biologicals for regulation under the act. Instead, organs will continue to regulated by the Australian Organ and Tissue Donation and Transplantation Authority established by this government and assisted reproductive tissues will continue to be regulated under current arrangements.

The new framework will enable the overarching regulatory principles that apply to all other therapeutic goods to be adapted and applied to biologicals by including a new part in the act. The principal benefit of the new biologicals part is its ability to apply different levels of premarket and postmarket regulation requirements based on the relative risk of each biological. It will also ensure that all biologicals used in Australia are properly assessed and regulated, as currently many are exempted and do not fit neatly under the medicines or medical devices frameworks. To enable this to occur, classes of biologicals will be set out in regulations to be made under this bill. The lowest class will include biologicals that are at a relatively low-risk level, while other classes will apply to biologicals of incrementally higher risk levels. For example, those biologicals that have been extensively manipulated or are intended to be used for a purpose that is not their usual or original purpose would fall under the highest risk class. The rigour of the application and assessment process and postmarket monitoring for biologicals will be aligned to these risk based classes so that higher risk biologicals will be required to provide a higher level of information to confirm their safety, quality and efficacy.

This approach means that sponsors of biologicals in lower risk classes are not required to comply with unnecessary requirements that are relevant only to the higher risk biologicals. Only those biologicals that are approved and included in the Australian Register of Therapeutic Goods or otherwise given an exemption under this new part will be able to be imported, exported, supplied or used in Australia. This is consistent with all other therapeutic pubic goods, such as medicines. The new part will also apply criminal offence and civil penalty provisions to dealings with biologicals in the same way as they apply to other therapeutic goods. Were this not the case, the act would be inconsistent in its application and sponsors of biologicals or other therapeutic goods might have an incentive to frame the claims in relation to the nature of their product so that it would come under the more lenient offence and civil penalty provisions.

A feature of the changes for biologicals is the ability to deal flexibly with urgent medical circumstances. Unlike medicines which may be readily mass produced, biologicals are produced from cells and tissues. As a result, the amount able to be produced and available on hand at any one time may vary. Also, there will always be minor differences between biologicals of the same product—for example, bone tissue from one donor will obviously not be exactly the same as bone tissue derived from another donor. The new part will require that all biologicals must meet certain standards and be manufactured according to good manufacturing processes and practice. However, there may be exceptional circumstances where a patient is critically ill and urgently requires a biological for treatment but none that conform to the requirements are available and no other approved therapeutic good is appropriate. This part will also provide that non-conforming biologicals can be used in such circumstances if, stringently, the patient’s doctor believes it is clinically necessary and the patient or their guardian consents. The decision to use non-conforming biologicals in exceptional circumstances would be made, as it is now, on a case-by-case basis by the doctor and the patient or their guardian.

It is important that this bill reflects the limited but critically important role for exceptional release. The bill provides that details for exceptional release will be set out in regulations. The requirements will be similar to those for access to unapproved medicines under category A of the current Special Access Scheme where patients are critically ill and no other approved therapeutic good is appropriate. Implementing the new arrangement proves the government is committed to making sure that sponsors and manufacturers of these products will be able to transition smoothly and easily to the regulatory arrangements so that the supply of biologicals to those who need them will not be affected.

As part of this commitment, the government has undertaken extensive consultation with the industry over the last 18 months, including explaining the proposed framework to sponsors and manufacturers, and setting out the steps they will need to take to comply with the framework. To further support the transition, the amendments in this bill establishing a framework will not commence until a date to be proclaimed within 12 months. This will ensure that the remaining consultation work on supporting details, such as the product-specific standards, can be finalised and in place to commence at the same time.

Schedule 1 also includes specific transitional provisions for any applications for inclusion of biologicals in the register as medicines or devices that are under consideration by the TGA at the time the new biological arrangements commence. Those biologicals will continue to be assessed as either medicines or devices, depending on which group they are currently regulated under. Where an application is approved, the biological will then be included in the register and moved to that part for biologicals. This will prevent applicants needing to make a new application or having the application assessment process being restarted or protracted as a result of the application being transferred for consideration by the biological assessment area. However, input into these applications is routinely provided by the biologicals assessors to ensure they meet the necessary standards. The existing arrangements in relation to advertising of therapeutic goods, review of decisions and other general provisions in the act will be applied to biologicals in the same way that they are for other therapeutic goods.

Through the cognate bill, associated amendments will also be made to the Therapeutic Goods (Charges) Act 1989 to enable annual charges to be payable by sponsors to maintain the inclusion of their biological in the register. These charges apply to all therapeutic goods and reflect the work of the TGA to monitor products on an ongoing basis. The biologicals industry sector has waited for a long time for this new framework and has begun readying itself to implement the new arrangements.

Schedule 2 of this bill replaces a number of currently somewhat inconsistent provisions that indemnify the minister, the secretary and others acting as required under the act with a single provision. The schedule does this by including a new section in the act to provide that the Commonwealth, the minister, the secretary, the national manager of the TGA and others empowered or authorised to do certain things under the act can do so without fear that civil legal action can be taken against them for doing so, as long as they do not act in bad faith. This is consistent with Commonwealth legislation for a number of other regulatory agencies such as the Australian Prudential Regulation Authority Act 1998 and others.

In other amendments under schedule 3 of the bill there will be provision for greater flexibility to recall specific batches of therapeutic goods where there are safety, quality, efficacy, presentation or performance concerns about any affected batches. Currently, in some cases where there are safety, quality, efficacy, presentation or performance concerns, the entire entry for a good must be suspended or cancelled in order to enable the recall of batches to occur. This approach is unnecessary and excessive in some circumstances where only a small number of batches are affected.

Consistent with the provisions included in the previous amendments, enabling information to be sought from a person who previously held a conformity assessment certificate for a medical device, schedule 4 of this bill enables information to be sought from people who previously had a medicine included in the register. Schedule 5 clarifies that unpaid annual charges are a debt due to the Commonwealth, to ensure that they are able to be recovered, as the TGA operates on a full cost recovery basis through the work it undertakes.

Finally, schedule 6 of the bill includes a number of minor amendments. These include providing that, where a person asks to vary the conditions of registration or listing for a medicine, the application for this must be accompanied by the relevant fee, to enable the TGA to assess and respond to the request. This will principally support postmarket monitoring of those medicines that are required to have an approved risk management plan as a condition of their registration and where the sponsor may wish to make a change to the agreed plan.

This schedule will also clarify what is meant by ‘new information’ in regard to reviews of decisions made under the act. So that now includes any information that a sponsor had at the time of the original decision but which was not provided to that decision maker. The amendments in this schedule support the minister or their delegate being provided with all pertinent information on which to make a decision, and remove a loophole that enabled such information to be withheld from that decision maker and lodged later for consideration by the Administrative Appeals Tribunal. Further improvements to the therapeutic goods regulatory regime introduced to parliament today will further round out improvements which we had as a government implemented throughout 2009.

I would like to make some comments—and to put at rest the mind of the member for Boothby—about the ability of the TGA to use discretion and to have flexibility in some of those processes. I would like to relate an anecdote about some pragmatic approaches that were recently taken by the TGA with its administrative allies—in this case, Medicare—in having appropriate flexibility to make regulatory changes while still being stringent as to the use of certain medicines and medical products. Late last year I was approached by two Gold Coast City councillors, Councillor Donna Gates and Councillor Jan Grew, about major concerns for their communities over the effects of diabetes on eyesight and that a certain medication, Avastin—used for retinal vein occlusions and severe diabetic retinopathy—due to a classification of use, was not being provided for certain ophthalmic procedures or for other uses in cardiac cases and other uses.

After representations to our minister, and departmental discussions through the TGA, I am pleased to report to this House that the critical needs of diabetic patients have been recognised. The appropriate changes were made to secure the use of Avastin—and, by the way, at a much lower cost to the government—not only to provide critical sight-saving injections but at a much lower cost to taxpayers—in fact, at about a 20th of the cost. This, of course, affects the whole of Australia. This is, as I said, an example of the stringent but flexible approach that is appropriate when you are looking at some of the regulation.

I would like to read an email from a retinal surgeon about this very issue. It goes:

Dear Brett

Please see attached re reversal of the TGA/HIC’s decision re item number 42740 as it relates to intravitreal injection of numerous important sight saving injections (E.g. Avastin for retinal vein occlusions and severe diabetic retinopathy, Triamcinolone for inflammation, antibiotics for serious intraocular infections …

May I personally thank you for the great efforts that you have brought to bear with respect to this welcome decision.

My patients have literally lived through a very dark era in the history of eye health care in Australia and the reversal of the November 2008 decision by TGA/HIC is very welcome.

This had caused huge heartache for many and they are all glad that this era has passed.

Once again, many thanks for your help with this issue.

That is an example of that flexibility. I know that on both sides of the House we would be pleased at least to have legislation and a framework that allows certain decisions, particularly in the case of critical medical need, to be addressed in that way. So credit goes also to Councillors Gates and Grew from the Gold Coast City Council for bringing this issue forward for their community.

This bill provides a substantial raft of improvements for all people, for Beenleigh and for all the seats in that South-East Queensland region. As the member for Moncrieff well knows, we do work very well together in the Gold Coast region and I see myself as the government member representing that whole region of South-East Queensland. I thank the member for his interjections and his support for the work we do collectively. I know the member for Moncrieff would have been frustrated in those 12 years under the previous government at the lack of ability of the previous government to support South-East Queensland. I am glad to see him here in the chamber today supporting what I am doing as the federal member for Forde and working for the Gold Coast region.

On a serious note, it is clear that these councillors from the Gold Coast City Council brought forward an issue that has surfaced not only their community, which is my community, but every community in Australia. It is so important that governments, irrespective of their political flavour, understand the need for legislation and procedure that allows for these decisions that at the end of the day are very important for and critical to medical outcomes.

In conclusion, this bill provides a substantial raft of improvements to the act and the regulation of therapeutic goods in Australia. Together with the wider regulatory reforms implemented last year, this bill will reinforce Australia’s international position as a leading therapeutic goods regulator. I therefore commend this bill to the House.

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