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

I move:

That this bill be now read a second time.

This bill 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 bill 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.

This bill 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.

As I announced in late June during the introduction of the previous amendment bill, this bill includes a new regulatory framework for cellular and tissue based therapy products, known as biologicals, so 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 it was among other improvements that were to have been adopted as part of the legislation underpinning the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA.

The Rudd government 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 have been passed by the Parliament this year and in this current bill that I put before the House today.

Schedule 1 of this bill 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 such things 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 be regulated by the Organ and Tissue Donation and Transplant 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 3-2A in the act. The principal benefit of the new biologicals part is its ability to apply different levels of pre- and post-market 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 the regulations to be made under this bill. The lowest class will include biologicals that are of a relatively low risk level while the other classes with 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 post-market 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 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 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 new part 3-2A for biologicals is its 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 not be exactly the same, obviously, 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 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.

The part will provide that non-conforming biologicals can be used in such circumstances if—and only if—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 reflect the limited but critically important role for exceptional release.

The bill provides that details for exceptional release will be set out in the 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.

In implementing the new arrangements, the government is committed to making sure that sponsors and manufacturers of these products will be able to transition smoothly and easily to the new 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 past year, 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 the framework will not commence until a date to be proclaimed within 12 months. This will ensure that the remaining consultation and work on the 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 applications for inclusion of a biological in the register as a medicine or a device that are under consideration by the TGA at the time the new biologicals arrangements commence.

Those applications will continue to be assessed as either a medicine or a device depending on which group they are currently regulated under. Where the 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 biologicals assessment area. However, input is routinely provided by the biologicals assessors into these applications 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.

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.

Turning now to schedule 2 of the bill, this schedule brings together the current range of somewhat inconsistent provisions that indemnify the minister, the secretary and others acting as required under the act and replaces these with a single provision.

This schedule does this by including a new section 61A in the act to provide that the Commonwealth, the minister, the secretary and others with powers and functions under the act, 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 in the bill, schedule 3 will provide greater flexibility to recall specific batches of therapeutic goods where there are safety, quality, efficacy, presentation or performance concerns about only those affected batches.

Currently in some cases where there are safety, quality, efficacy, presentation or performance concerns the entire entry for the good must be suspended or cancelled in order to enable 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 Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 which enable 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 final schedule of the bill will also clarify what is meant by new information in regard to reviews of decisions made under the act so that it now includes any information that the sponsor had at the time of the original decision but was not provided to that decision maker. This is referred to as initial new information. It will also include any information that the sponsor had at the time the original decision was reconsidered and a new decision was made, but was not provided to the minister or their delegate. Such information is referred to as later new information, reflecting that it relates to the later review of the original decision.

This will ensure that where such information exists the original decision maker or the minister is given the opportunity to review it and make a decision having taken it into account. Currently the later new information can be provided directly to the Administrative Appeals Tribunal as part of a review of a decision made under the act and the tribunal does not need to remit the matter to the original decision maker to give her or him the opportunity to consider it.

The amendments in this schedule will support the minister or their delegate being provided with all pertinent information on which to make a decision and remove a loophole that enables such information to be withheld from that decision maker and lodged later for consideration by the Administrative Appeals Tribunal.

The government intends to make further improvements to the therapeutic goods regulatory regime in the coming year to round out the improvements implemented through legislative amendments this year.

In particular, we intend to introduce further legislation to improve the advertising arrangements for therapeutic goods which are broadly acknowledged to be less than ideal at present.

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 already this year, this bill will reinforce Australia’s international position as a leading therapeutic goods regulator. I commend the bill to the House.

Debate (on motion by Dr Stone) adjourned.