Slade Brockman (WA, Liberal Party) Share 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 It's about enhancing consumer protection by replacing an outdated advertising and complaints process, one that had, in particular, failed to take into account the increasing use of things like the internet to promote products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.