Helen Polley (Tasmania, Australian Labor Party, Shadow Assistant Minister to the Leader (Tasmania)) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017 primarily implement reforms flowing from the expert panel review of medicines and medical devices, also known as the Sansom review. This is the second tranche of legislation following the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, which was passed in the middle of last year. These bills were referred to the Senate Community Affairs Legislation Committee on 30 November and the committee handed down its report on 2 February.

I turn now to the detail of the legislation. Schedule 1 of this legislation provides a pathway for the provisional registration of promising new medicines. These will be included in a new class of therapeutic goods, which will be known as provisionally registered goods. Sponsors will be able to apply for this provisional registration subject to the Therapeutic Goods Administration reviewing and accepting early clinical data on the efficacy and safety of the medicine. That registration will be limited to a two-year period, although they may apply for up to two extensions. Sponsors will also be required to comply with additional conditions relating to the efficacy and safety of these medicines after it is available on the market.

Whether we are talking about medicines, medical devices or procedures, there are always risks. In many cases those risks may be very low, but they are there and patients often do not fully appreciate this until after something has gone wrong. The potential risks must, however, be weighed against the potential benefits. In many situations it is the patients themselves who must weigh up these risks and benefits, hopefully with the guidance of health professionals. Patients who are presented with the same risks and benefits may well reach different conclusions about what is right for them. Even with medicines that have been in use widely and for a long time, new information may become available. That new information may improve our understanding and change either side of the risk-benefit ratio.

Recognising that these medicines are based on early clinical data, it's important that doctors, health professionals and, most importantly, patients fully understand and appreciate the risks involved. With access to a medicine being given without the level of clinical data that would normally be provided, it is foreseeable that new information will show some of these medicines to be less effective than first thought, and there may be greater or new risks that weren't known at the time. Of course, the opposite could also occur. There will be strict conditions under which a medicine will be available through the provisional approval pathway. It will be for patients with unmet clinical needs for serious health conditions.

These bills also reform the regulatory framework for complementary medicines. These reforms include: establishing a list of permitted indications for listed complementary medicines by the minister through a legislative instrument; creation of a new assessment pathway for listed complementary medicines; and allowing sponsors to claim evidence of efficacy. Complementary medicines fit into two categories: they are listed or registered. Listed medicines are assessed for quality and safety by the TGA. However, they are not assessed for efficacy. Registered medicines are assessed by the TGA for efficacy in addition to quality and safety.

Schedule 2 of the bill allows the establishment of the permitted indications list, which removes the option of a free-text field for sponsors and allows only pre-approved low-level claims to be made. The National Boards and the Australian Health Practitioner Regulation Agency stated in their submission to the Senate inquiry that the current system:

… will be greatly strengthened by the removal of the free text field for indications and replaced by a more controlled approach to permitted indications.

This was an area where stakeholders' views diverged greatly. Many stakeholders made submissions to the inquiry suggesting that there should be a disclaimer in relation to indications based on traditional evidence, stating that there is no scientific evidence of efficiency.

Schedule 3 of the bill creates a new assessment pathway for listed complementary medicines and provides an option for sponsors who want to use indications that are not on the permitted indications list. In this case, the TGA would assess the evidence of the efficiency, and the sponsor would certify the quality and safety. Sponsors would then be able to indicate in their promotional material that medicine had been assessed.

Schedule 4 amends the act to provide classification so that it more accurately reflects existing administrative practices. For example, an application must meet primary requirements before it can further proceed. It makes little sense to waste resources further processing an application if that application is clearly deficient.

Schedule 5 provides changes to the act in relation to Australia's conformity assessment body. This was a major part of the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 and ensures that the TGA has the power to obtain documents relating to certification activity from these bodies and the manufacturers whom they have certified. It also enables the greater use of assessment by overseas regulators for medical devices.

Schedule 6 makes changes concerning the advertising of therapeutic goods. It allows for the TGA to be the single body responsible for management of complaints about advertising of therapeutic goods. It also broadens the sanctions and penalties available in relation to misleading advertising.

Part 2 of schedule 6 reviews existing requirements for pre-approval of certain advertisements. Presently, there are inconsistencies in which therapeutic goods require pre-approval before they are advertised to the public. For example, medical devices do not. The inconsistency also extends to the media in which goods are advertised, with over-the-counter medicine advertisements being subject to pre-approval on television, on radio and in print; however, those same goods don't need pre-approval when advertised on the internet.

The removal of the pre-approval process appeared to be the primary concern that arose from the Senate inquiry, with many civil society groups expressing alarm. CHOICE in its submission stated:

The responsibility for pre-vetting advertisements is currently split between two bodies; Australian Self Medication Industry (ASMI) and Complementary Medicines Australia. The Advertising Standards Manager at ASMI reported that in 2014/15, ASMI reviewed over 1,400 advertisements with an average turnaround time of 7 days. She noted that during this period, the majority of new advertisements assessed required changes to avoid breaching the Therapeutic Goods Advertising Code, sometimes wholesale revisions. Considering this, it is evident that this process is essential in protecting consumers against false and misleading advertising. Ceasing pre-vetting opens a floodgate of issues – advertisers can say anything they want and, while the TGA has enforcement powers, once an advertisement has been aired or published, the damage has been done and consumers are unwittingly misled.

Before any changes to this process are made, we strongly support a formal independent review of the system. Sufficient evidence should be collected that demonstrates that there is no need for pre-approval of adverts before such a decision is made.

The Public Health Association of Australia also expressed those same concerns in its submission:

The PHAA is concerned about abandoning pre-approval of advertisements without a formal review of the effectiveness of the proposed reform package. We note that the majority of published submissions to the TGA consultation on advertising reforms did not support removal of pre-approval in favour of self-regulation; with all those supporting the changes coming from industry or media organisations.

Although there is room for improvement, the current pre-approval process is largely efficient and effective. It reviews over 2,000 advertisements per year with an average turnaround time of 7 days, and identifies changes required in most advertisements it reviews to bring them in alignment with the Code. Prevention is better than cure, and the current Bill replaces a co-regulatory scheme of known effectiveness with a self-regulatory scheme of unknown effectiveness. This is particularly important for media advertisements, which may persist even once found to be in breach of the Code (for example, remaining in print media indefinitely).

Those reviews were echoed by many others. The core issue is that, if the pre-approval system is abolished, any protection can only be applied after the damage is done. Labor accepts that this legislation does provide positive measures including the improvement to post market surveillance, stronger penalties for a regulatory violation and a new complaints handling system. However, what we don't know is whether those measures will be sufficient to remove the pre-approval system without risking the increased harm that comes from misleading advertising.

This legislation implements many complex reforms. A further concern is whether implementing all of these changes in a very short time frame will overload the capacity of the TGA. Schedule 7 will allow for powers of search and entry to monitor compliance with the act. It will also allow for more graduated penalties to contraventions of the act so that the response to breaches of the act can be more appropriate to the severity of the breach. Schedule 8 makes amendments to ensure that the record keeping and reporting requirements of biologicals are consistent with other medicines. Schedule 9 makes some minor amendments to the act including improving consistency with different types of therapeutical goods.

Finally, the Therapeutic Goods (Charges) Amendment Bill 2017 primarily allows for regulations to be made to prescribe an annual charge for a conformity assessment body determination and to ensure that annual charges will also apply to provisionally registered goods entered in the Australian Register of Therapeutic Goods.

Schedules 4, 5, 8 and 9 were not controversial, and the committee heard no evidence of any concerns about the measures in those schedules. The charges bill was not of great concern, with little discussion of this bill in the inquiry submissions.

I now return to the main issue Labor had with this legislation, the removal of pre-approval process for advertisements. Labor drafted an amendment to retain the pre-approval system; however, we welcome Minister Hunt's willingness to negotiate on this matter. The government has agreed to retain the mandatory pre-approval system for two years subject to an evaluation at 18 months. We understand that the government will therefore now be moving its own amendment. Whilst we accept that some concerns remain, on balance, Labor believes that these bills are an improvement over what exists. The government's amendment and other non-legislative commitments made by the minister in his letter to Labor's shadow minister for health on 4 February this year addressed the most serious concerns we had. Labor will therefore support the government's amendments and the bill without further amendment. This will allow for swift passage of the legislation, and the provisional approval pathway for promising new medicines will be very important for patients awaiting treatment.

Richard Di Natale (Victoria, Australian Greens) Share this | Link to this | Hansard source

I rise to speak to Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. This is the second tranche of legislation arising from the Sansom review, which was an expert review of medicine and medical device regulation. It was a review that was long overdue. The Greens supported the review and we support most of the recommendations that have come from that review. The reason, in fact, we're standing here today and speaking about the report of the findings of the Senate Community Affairs Legislation Committee is because the Greens moved this bill to an inquiry. It was through that process we learned of the significant concerns of a number of stakeholders. We referred this bill to inquiry because we had a number of concerns about the bill, particularly in relation to schedules 2 and 6.

The TGA plays a very important role in Australia. It ensures that we have a regulatory body that assesses medicines that come into this country and ensures that the claims made about therapeutic products are substantiated and that people get access to therapeutic products in a timely way. It must be said that there are significant elements of this bill that we do support and are keen to see come into effect as soon as possible with regard to the regulation of therapeutic goods in Australia. Part of the reason for this legislation is ensuring that people get timely access to medicines. That's an important change. Changing the fast-track registration process does mean that we're going to get effective treatments into the hands of patients sooner than they otherwise would've been able to get access to those medications, and some of these medications may indeed save lives. It's a very important change and one that we welcome. But, as I said earlier, we do have some concerns about this bill. While we support changes to the fast-tracking process and other changes to therapeutic goods registration, there are other changes in this bill that we think have the potential to undermine consumer protections.

Schedule 2 of the bill allows the minister to determine the list of 'permitted indications' that can be made for medicines listed on the register of complementary medicines. At the moment, what you have is a process for listing a complementary medicine on the Australian Register of Therapeutic Goods that allows the sponsor of that medicine to include a free-text description of the indications for the products. It basically allows the people who are sponsoring a product to write what they like about the product, to walk that line—and sometimes walk cross that line—between a claim that may have some merit and one that is clearly in the interests of getting the product moving through into consumers' hands.

The change to determine a list of permitted indications is something that might be supported, provided that it comes with what was also recommended through the Sansom review. As I say, the removal of the free-text option is a good thing. It provides some boundaries around what the sponsors can say about products. The list of permitted indications was originally a very well-defined list, but pressure from industry has meant that we're going to see a much larger list of permitted indications than we otherwise might have. It's also going to be within the discretion of the minister. This is a power for the minister via a legislative instrument to establish that list of pre-approved permitted indications. We have to remember that that happens without any formal assessment by the TGA. The sponsors will look through a list of permitted indications and choose which one they think is appropriate for their product, but that doesn't mean that the product has been rigorously assessed by the TGA to determine that those claims can be made.

The Sansom review did recommend this change. They said, 'Get rid of the free-text option, but you need to replace it with a list of permitted indications.' But they also did it in combination with a further recommendation that there should be a disclaimer on those medicines so that consumers are aware that they haven't been tested for efficacy, and that, while this claim might be made by the sponsor, this is not something that has been proven through an assessment by the TGA. That's very important. A number of stakeholders from a range of sectors raised their concerns about this with the committee, and they made it very clear that it was important that this additional disclaimer be inserted to make sure that the list of permitted indications are seen within their proper context. Just because the TGA have said, 'This is our list of indications, and we've said to you, "You can choose one of these," it doesn't mean that we endorse or have assessed your product to ensure that it complies with that indication.' The Sansom review said there should be a disclaimer that says explicitly: this doesn't mean that these claims have been assessed or verified by the TGA or that they're supported by the TGA. That was the view of a number of stakeholders—for example, the Consumers Health Forum of Australia. We all know who the Consumers Health Forum are. They basically advocate for patients to ensure that they have the right information to make the right choices to get access to medicines. They said:

Our concern is that the limitations of this list of permitted indications may not be understood by many consumers and it may give them some misplaced confidence in the evidence behind the list.

We also heard a similar sentiment from the Royal Australian College of General Practitioners, which is obviously the group that represents GPs here in Australia. It said:

We strongly recommend that the TGA mandates that manufacturers must include a statement to accompany all non-scientific therapeutic claims, in close proximity and in the same font as the health claim.

It must be said that the TGA have been generous with their time in providing us with briefings, and we certainly appreciate that, and I understand that the rationale for their not endorsing that recommendation from the Sansom review is that they believe it won't make a difference. My argument in return would be: if it doesn't make a difference then there should be no issue in terms of including it.

I think it does behove our regulatory authority to ensure that consumers have all the right information in front of them and aren't led to believe that a particular claim made by the sponsor of a therapeutic product has somehow been assessed and endorsed by the TGA. As a result of these concerns I can indicate that the Greens will be moving an amendment in my name that would see the requirement for the disclaimer, as was recommended by Professor Lloyd Sansom in his review.

The second issue is the issue of the deregulation of advertising and the removal of preapprovals. Schedule 6, part 2 of this bill removes the current system of preapprovals for advertisements of therapeutic goods. Currently, if you're a sponsor of a particular medicine and you want to advertise it, you're submitted to a pre-vetting process. The ad is submitted to a pre-vetting process under a power that's delegated to the Australian Self Medication Industry and Complementary Medicines Australia. That's to ensure that it meets approved standards.

A number of people who submitted to the inquiry raised concerns about the removal of this current layer of oversight, which guards against the distribution or broadcast of ads that are in breach and which protects consumers from misinformation about any of the claims made in that ad, including those which might be about the efficacy or indications of the products. The submitters said we shouldn't remove that level of oversight.

The Australian Self Medication Industry estimated in their submission that 60 to 70 per cent of advertisements submitted to ASMI's advertising services office for preapproval required some form of amendment. Some 60 to 70 per cent of ads submitted to the Australian Self Medication Industry advertising services office were changed. They needed to be changed. It might have been a minor change or a significant change. Some of the changes were small; some were significant changes to the claims that were made through the ad. That's a lot of ads, many of which, if they'd not been pre-vetted, would have been broadcast, meaning that consumers would have been exposed to false or misleading claims.

We don't see why you would seek to change a system that protects consumers. The Australian Greens concur with the concerns raised by many of the stakeholders about this change and that there is little sense in removing this layer of regulatory protection, at least not until we have seen what the replacement regime looks like. The change seeks to implement a range of new sanctions for breaches. We want to make sure that the effectiveness of these new sanctions have been assessed and reviewed through the formal three-year review of the reforms, which the government has already committed to. Therefore, I also want to highlight that the Australian Greens will move a further amendment—that the removal of preapprovals for therapeutic goods advertising be delayed at least until after the three-year review of the reforms to the advertising regime.

Our amendments also legislate for that review to take place and for public reporting of its findings. It's very important that that occurs. I understand that the government has written to the Labor Party and that there has been some discussion between the government and the Labor Party—both of whom, it must be remembered, were prepared to see this bill go through without any changes and without any amendments. But I'm pleased it appears that the government has written to the Labor Party and made a commitment for a non-mandatory preapprovals service for two years. It's an improvement, but it's still not good enough. The commitment won't, as I understand it, be statutory. It means that the government, of course, won't be amending the bill to make sure this occurs. If there's a change to that, I look forward to hearing from the government on that point. I'm surprised that the Labor Party would agree to that and, effectively, roll over on that change, because if they want a guarantee that we don't remove protections for consumers, then they need to make sure that the change is legislated. That's why they should be supporting the Greens' amendment—to ensure, in law, that the preapprovals process remains in place until the review is concluded. I always worry about handshake agreements between governments and oppositions: governments change, prime ministers change, ministers change. It is important that this change should be reflected in law.

I understand that the letter from Minister Hunt to the Labor shadow minister sets out a range of non-statutory commitments. It is a series of commitments which the government has already made through the process of the committee inquiry. Again, I remind you that it was initiated through the Greens, so it is pleasing that we have some change in that area. But I do, again, stress my concern that without the appropriate legislation we cannot guarantee that this change will be binding. I think that the Labor Party was a little hasty in accepting the list, but, again, I hold out some hope that they may support our amendments.

Let me conclude by saying that we are, of course, very supportive of Australians having access to complementary and traditional medicines. We think it's very important to give people access to both of those things, to ensure that the traditional use of medicines continues and that complementary medicines are made available to people who feel they may be of benefit. But we think it's very important that consumers are protected from false or misleading claims or ads which can confuse people about the level of evidence supporting these claims and the level of regulatory oversight for these products. Let's not forget this is very big business. This is a multibillion-dollar industry; there is a lot of pressure that comes to bear on our regulatory authorities to ensure that the pathway is cleared for industry. What that often means is that that comes at the cost of protections for consumers. I hope that the government might see fit to acknowledge that these commonsense amendments by the Greens are worthy of support. And, at the very least, I hope that the Labor Party and the crossbench will join the Greens to uphold consumer protections by supporting the Greens' amendments.

Slade Brockman (WA, Liberal Party) Share this | Link to this | Hansard source

I welcome all back to the start of a new parliamentary year, and I would particularly like to thank, just as he walks out of the chamber, our newest colleague, Senator Molan. Welcome, it is great to see you here.

I rise to speak on the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017. Obviously, therapeutic goods and medicines are an increasing part of the increasing standard of living that we have experienced through the 20th century and into the 21st century, and they play an extraordinary role in giving us the long and healthy lives that we are privileged to enjoy.

The Therapeutic Goods Administration, as the regulator, ensures that therapeutic goods available in Australia are safe, effective and of high quality, with the latest therapeutic goods advances being made available to the Australian public in the most efficient and effective way possible. These are the priorities that drive reform from this government and, as we've heard, drive reform coming out of the medicines and medical devices regulation review, which commenced in 2014.

What benefits flow from the changes that are being made in this space? The key benefit from my point of view is that it's about getting medicines more quickly to those who desperately need them—in some cases up to two years earlier—but with the necessary checks and balances to maintain patient safety. It's about enhancing consumer protection by replacing an outdated advertising and complaints process, one that had, in particular, failed to take into account the increasing use of things like the internet to promote products in the marketplace, which wasn't adequately covered under the old system. It's about simplifying, for enhanced consumer confidence, self-selected medicines by limiting the claims that can be made by sponsors of complementary medicines. It also provides the TGA with appropriate powers, similar to those of the ACCC, to take action against those who do not comply with the new regulatory regime.

The bill has extensive support amongst many groups, including industry groups, professional bodies and consumer groups. There has been extensive consultation on this bill and reform package, going back to legislation from last year. There have been 16 public consultations on the details of the medicines and medical devices review, for example. There will be ongoing public consultation to continue a high level of stakeholder input to the shape of this important work—public consultation is already planned for 2018. As we in this place know very well, legislation is never the end of the story. There is an implementation phase and there are ongoing monitoring of and changes to legislation, all of which are a very important part of the public policy development process. So the consultations in 2018 are a very important part of the ongoing implementation of this legislation.

This bill was referred to the Senate Community Affairs Legislation Committee, of which I am chair. The committee received 55 submissions and reported recently. The majority report made four recommendations, which I will go through briefly. The committee recommended that the government ensure the TGA continue to carry out comprehensive, appropriate and timely consultations with industry and other key stakeholders, particularly in relation to legislation and regulations affecting the TGA regulatory framework. Obviously, as I have stated, this is a very important area, because the TGA and the government need to be constantly monitoring developments in the marketplace. The current regulatory regime clearly has not kept up with things such as direct advertising through the internet and websites promoting particular products with potentially outrageous medical claims. So the framework needs to be constantly monitored and consultation needs to be constantly engaged in with both industry and the general public to ensure that our regulatory framework remains up to date.

The committee noted the importance of self-regulatory models and recommended that the TGA investigate ways to better support the effective functioning of self-regulatory models by industry, including the potential for further strengthening of the penalties regime if needed. This bill does strengthen the penalties regime, but obviously it is an area where we as a government and a society need to make sure we get the carrot and, particularly in this case, the stick right. Penalties need to be appropriate and timely, and they need to be able to enforce compliance in a proactive way to make sure that people will not take the risk of making outrageous health claims, unsupported by the evidence, to try to drive business.

The committee also recommended that the government ensure that the Therapeutic Goods Administration is adequately resourced in accordance with its cost-recovery framework so that it is able to carry out its surveillance and monitoring functions in relation to advertising compliance. Obviously, when you go to a self-regulatory model you need to have the resources to make sure that monitoring is taking place and that the TGA is adequately resourced, through its cost-recovery framework, to do proper monitoring.

Those were the three main recommendations. The fourth recommendation was that the Senate pass the bill, and it seems—and I thank the Labor Party for their support—that the Senate will be passing this bill. The government was happy to accept the recommendations of the committee and noted that they could be readily implemented by the TGA.

As we've heard quite extensively Labor's position on the bill, I will briefly talk through some of the amendments proposed by the Greens. First is the idea that additional caution is required for the removal of mandatory pre-approvals. The bill has additional protections to support the removal of pre-approvals, including a screening service, which has been talked about. There will be additional governance and performance reporting to improve the visibility and transparency of advertising compliance processes. As well, there is going to be a comprehensive education program.

There is also the issue of the disclaimer. There have been extensive consultations on the permitted indications list, and we believe that, in conjunction with the new penalties and the comprehensiveness of the permitted indications list, a further disclaimer is not necessary. There is evidence from the United States that a strong disclaimer has no real impact. In that context it is something, I think, that should be looked at further in the future, but the government, at this stage, does not support it.

I will go to some of the more detailed aspects of the bill, in particular the priority pathway. The bill includes provisions supporting a new pathway to allow sponsors to apply for a time-limited provisional registration of certain prescription medicines that show potential for substantial benefit to Australian patients. This means that, with appropriate controls, Australians will have access to new and expanded use of medicines up to two years earlier than would otherwise be the case. Provisionally-registered medicines will be subject to TGA requirements to confirm the clinical benefits and safety of the medicines and ensure that patients and healthcare professionals are fully informed about any risks of using the medicines. Obviously, the process for the registration of medicines in Australia is quite a complex and time-consuming one. There are medicines developed elsewhere that potentially could be of benefit to a limited number of patients in Australia, and this change to a priority pathway will, in certain circumstances, speed up access to those medicines.

The Department of Health is working to ensure the appropriate alignment of regulatory and reimbursement processes for those new medicines. There are going to be enhanced post-market monitoring mechanisms. These will include the prominent display of a black triangle on the product information leaflet used by prescribers, easier reporting of adverse events, practitioner education and legally binding obligations on sponsors to ensure the TGA has the most up-to-date information for the use of the medicine in Australia and overseas so that safety in using those provisionally approved medicines is always paramount. Obviously, in the healthcare sector, when you're introducing a new pharmaceutical there's always a balance between benefit and potential harm. This is an attempt to get the balance right, to bring in potentially life-saving pharmaceuticals in a timely fashion where such safety checks have been carried out.

On the advertising and complaints changes: the Therapeutic Goods Administration will become the single agency dealing with complaints management. This will reduce complexity and encourage greater consistency and timelier decision-making, replacing an antiquated and cumbersome system with a simplified approach underpinned by good governance and clear performance reporting. These new arrangements will benefit advertisers, health professionals and consumers by providing timely and consistent decision-making, compliance and enforcement. A new TGA committee will be established to provide visibility and transparency over TGA's management of advertising and complaints. This will have representatives from industry, professional bodies and consumer groups.

Again, to return to the issue of removal of mandatory preapprovals: it should be noted that mandatory preapprovals for therapeutic goods do not exist anywhere else in the world. Current preapprovals do not cover medical devices, nor do they cover all methods of advertising—as I mentioned earlier, the internet being the prime case in point. A mandatory preapproval system that ignores the new principal way in which people receive information like this is obviously a flawed system. Its removal will be supplemented with greater education to the industry, control of complementary medicine claims through a set of permitted indications and by the TGA taking appropriate actions through enhanced penalties and sanctions for those who don't comply. As I mentioned earlier, we need to make sure those penalties are robust enough to ensure compliance.

On complementary medicines: the changes to complementary medicines will establish a list of permitted indications and require sponsors of listed complementary medicines to select indications exclusively from the list when entering a medicine on the ARTG. This will make clear to consumers the claims that sponsors are making, better supporting those who choose to self-medicate in this way. Only low-level indications suitable for low risk will be permitted. Indications for listed complementary medicines may not refer to the treatment or cure of a disease, ailment, defect or injury or to a serious form of disease, ailment, defect or injury. Providing a list of permitted indications will ensure that listed medicines only contain preapproved, low-level claims appropriate for medicines that are not premarket assessed. This will provide greater protection for consumers in relation to safety, quality and efficacy of products available on the market.

Finally, on sanctions and penalties: the new enforcement provisions will give TGA further tools for its regulatory toolkit to enable them to deal appropriately with those who do not comply. Existing provisions will be enhanced and new enforcement options introduced. For example, injunctions can be sought to rapidly and effectively address serious cases of non-compliant advertising of therapeutic goods—for example, an alleged cancer cure which may deter critically ill people from seeking appropriate treatment. There's also the power to issue infringement notices as an alternative to court action so that noncompliance can be addressed in a timely manner. Again, that is a very important addition to the TGA's regulatory toolkit. These new provisions will work together with consumer law regulators, such as the ACCC, to ensure the safety, quality and efficacy of therapeutic goods.

In conclusion, this bill, together with recent amendments already enacted, strengthens Australia's therapeutic goods regulatory framework. It ensures that Australia remains well positioned to respond to global trends in the development, manufacture, marketing and regulation of therapeutic goods. It makes Australia a more desirable destination for clinical trials and for the manufacture and development of medical devices. It will deliver better health outcomes and better economic outcomes as a result. Ultimately, this is an opportunity for us to make these vital reforms to the regulation of therapeutic goods in Australia, which will ensure better access to medicines, streamlined administrative processes and strong consumer protections.

Bridget McKenzie (Victoria, National Party, Minister for Regional Communications) Share this | Link to this | Hansard source

I'd like to thank senators for their contributions to the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. The amendments in this bill provide for a number of reforms to Australia's therapeutic goods regulatory framework, to ensure it remains well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods. We all know how important medicines and medical devices are to the wellbeing of all Australians. We also know how important it is to ensure that the therapeutic goods available in Australia are of an acceptable safety, quality and efficacy, and that Australia's regulatory framework for therapeutic goods remains current with the rapid pace of innovation in the development of health products globally.

These amendments continue the implementation of the government's response to the Expert Review of Medicines and Medical Devices Regulation, which indicated support for 56 of the 58 recommendations for reforms to the regulatory frameworks for medicines, medical devices, complementary medicines and advertising of therapeutic products. The expert panel review was informed by a large number of submissions—in the order of 100—as well as a number of consultations held by the expert panel with stakeholders. Individual panel members also held informal discussions with stakeholders and their representatives.

In implementing the government's response, the department, through the TGA, has undertaken a number of significant public and targeted stakeholder consultations regarding the approaches for the implementation of the recommendations. Sixteen public consultations have been released to date, with feedback indicating general support for the overall policy changes. Stakeholders also provided advice on how best to implement the reforms. A stakeholder information day was held at the TGA offices on 4 September 2017 on this amendment bill. Approximately 60 stakeholders attended, representing consumers, health professionals, sponsors, broadcasters and advertising bodies.

In considering the Expert Panel Review of Medicines and Medical Devices Regulation, the government formed the view that overall the reforms strike the right balance between consumer protections and reducing regulatory burden for companies importing or manufacturing new medicines, medical devices or complementary medicines. The measures in this bill provide significant reforms in relation to establishing a provisional approval pathway for promising new medicines that address an unmet client need, allowing patients to have earlier access to potentially lifesaving or life-transforming medicines. The regulation of complementary medicines provides consumers with more informed product choices via a new assessment pathway which allows for efficacy-assessed-listed complementary medicines and introducing a streamlined approach to the advertising framework for therapeutic goods, coupled with improved compliance and monitoring provisions. Amendments enabling the greater use of assessments from comparable international regulators will allow for medical devices to reach our market sooner.

In considering these bills in the Federation Chamber on 25 October 2017, the member for Makin, the shadow minister for Medicare, Mr Zappia, indicated the Australian Labor Party's support for the bill. He indicated they did so because they agree that, on balance, the reforms are in the public interest, and we are pleased that that support has continued here in the Senate. We had extensive feedback from key stakeholders as part of the Senate Community Affairs Legislation Committee inquiry into the bill and from many senators here today.

The government has listened to this feedback, and further measures will be introduced to reassure Australians that they can have confidence in the regulation of medicines and medical devices. These include further strengthening provisions relating to advertising, including improved governance through the establishment of a therapeutic goods advertising committee, and performance management to ensure stakeholders have visibility and transparency of the advertising system. These additions will help to ensure that appropriate safeguards are in place in relation to the advertising of therapeutic goods to the public. Furthermore, to address concerns associated with the move away from pre-approval of advertisements to a self-regulated regime, we have agreed to some minor amendments that will see the transition from the pre-approval delayed for two years. We've also agreed to some non-statutory initiatives, including an evaluation of the system after 18 months. I understand the amendments agreed to with Labor are being circulated now, and I thank Labor and the crossbench for their engagement on this issue.

This overhaul of the advertising framework will provide consistency, transparency, and stronger compliance measures, and will retain a consultative approach to ensure that consumer protections are maintained. While we've focused on advertising, the bill, importantly, includes a package of reforms to the regulation of medicines and medical devices that provides benefits to consumers. Of particular benefit is establishing a provisional approval pathway for certain promising new prescription medicines. This will allow Australian patients with inadequate treatment options to access potentially lifesaving or life-transforming medicines up to two years earlier than under the current framework, and it builds on similar approaches available to patients in Europe and in North America. Some medicines will be registered on the basis of early clinical data which provides promising evidence that the medicine is likely to be of major therapeutic advantage to Australian patients. Provisional registration will be time limited and subject to strict conditions imposed by the TGA, including the requirement to collect more data to confirm the clinical benefit and safety of the medicine, and there will be specific communication with patients and healthcare professionals about these medicines.

The introduction of the provisional approval scheme for medicines will enable desperately ill patients to access new medicines up to two years sooner. Importantly, the bill will also provide patients with greater access to medical devices. Improved access to new medical devices will also be enabled through the use of assessments from comparable international regulators that will allow for medical devices to potentially reach our market sooner. There will be streamlined public awareness of products that support public health, such as tests for sexually transmitted diseases.

This bill, coupled with the recent amendments enacted last year, will strengthen Australia's therapeutic goods regulatory framework, ensuring it remains at the forefront to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

Debate adjourned.

Ordered that the resumption of the debate be made an order of the day for the next day of sitting.