Tim Hammond (Perth, Australian Labor Party) Share this | Link to this | Hansard source

Prior to the time in which members' 90-second statements began I was taking the House through aspects of the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. I made the point that the bill as amended will ensure the capacity to refuse to list in the Australian Register of Therapeutic Goods, or the ARTG, as it is more commonly known, medicinal products that have the potential to undermine Australia's public health efforts. The bill will also require listed medicinal products to only include ingredients that have been approved for use in listed products.

I am pleased that the government has made provisions for these measures in the 2016-2017 budget and out into the forwards. In a time of constrained resources, I am particularly pleased that it is within a sustainable cost recovery model. I understand that $20.4 million over four years has been allocated to approving TGA regulation and that, from the next financial year, the cost recovery mechanism will cover future ongoing costs.

I will now outline to this place what consumer bodies think about this bill. From what I understand, generally , stakeholders such as Medicines Australia, Pharmaceutical Society of Australia, Complementary Medicines Australia and Generic and Biosimilar Medicines Association have been supportive of this bill. Given this bill will make it easier for those organisations and the companies they represent to bring the products to market , this, in i t s elf, is unsurprising. Indeed , I would be very concerned if these organisations had come out against it.

As the shadow minister for consumer affairs, I think it is important to also view this bill from the consumers' perspective. I am conscious that there is a balancing exercise here between rapid processing of medicines and devices and safety for consumers and families. We should always be ready to amend rules and put checks and balances in place to ensure that products in Australia are safe and are appropriately risk assessed. Moving towards the risk-based approach foreshadowed in this bill will require the TGA to perform rigorous and best-practice risk assessments.

Dr Martin Whitely, a former member for Bassendean in my electorate and now a researcher with the Health Consumers' Council, made a submission to the Senate committee accepting the benefits of 'streamlining' the TGA's approval processes, but warned that there remains a need for rigorous safety and transparency processes to improve upon the safety and efficacy of medications. Meanwhile, the Consumers' Health Forum of Australia, the national peak body representing the interests of Australian healthcare consumers and those with an interest in health consumer affairs, also supported the government's approach, with their CEO, Leanne Wells, welcoming the fast-tracking of assessments for medical devices and medicines in her response to the minister's announcement of the government's response to the Sansom review last year.

The CHF's chief concern was about cost to consumers. Streamlining of the TGA process will get medicines to market quicker, but many will still be prohibitively expensive until they receive Pharmaceutical Benefits Scheme listing. And I know that a number of pharmaceutical companies have also called for so-called parallel consideration of new medications so the TGA and PBS can consider them and approve them concurrently, rather than successively. CHF also stated in September 2016:

CHF is concerned that regulation of complementary medicines, which have been the subject of ongoing controversy concerning questionable advertising, has not been tightened up sufficiently.

We support a simpler pathway to "register" evidence-based complementary medicines this will need more public education to convey the difference between "listed products" which do not have evidence of efficacy, the proposed new approval category of products backed by some evidence and "registered" products which are backed by good evidence of efficacy …

In relation to strengthening post-marketing activity, schedules 8 to 11 in this bill improve the post-market monitoring scheme for medicines. This is important, and includes record-keeping requirements and empowers searching of premises to ensure compliance. Improvements have also been made to rules around recall information, specifically to grounds on which the secretary may require recall actions to be taken, and allowing the secretary to inform the public or specified persons of recall information about goods. It was also good to see powers for the secretary to better manage shortages of goods.

However, as identified by consumer groups, there is room for improvement. Firstly, concerns have been raised by the Senate Standing Committee for the Scrutiny of Bills, including about some strict liability offences—for instance, for health practitioners who do not comply with the notification requirements of the scheme—reversal of the evidential burden of proof in relation to some offences, and impacts on the privilege against self-incrimination. I note that this bill leaves much detail to delegated legislation. Labor referred the bill to the Senate Community Affairs Legislation Committee due to concerns that many changes will be made by regulations that have not yet been drafted. I think too often parliament is tempted to defer too much of its power to delegated legislation. I would say to the minister that the opposition will be closely scrutinising regulations pursuant to this bill. There were issues raised about how conformity assessment bodies will operate. These are essentially third parties who will undertake conformity assessment of devices and their manufacture to ensure they comply with safety principles. The secretary is again able to delegate their powers in a number of areas in the bill. Again, if this delegable power is used to avoid proper scrutiny then it will be cause for significant concern.

As shadow minister for consumer affairs, I am particularly interested in how we continue to monitor safety concerns with therapeutic goods. I would like to make sure that we have a very robust system of post-market safety alerts and post-market recalls, to make sure that safety, quality and marketing issues are identified and, most importantly, resolved quickly. Whilst there are elements of self-regulation within this bill, it must be monitored to make sure that compliance is being enforced. I will end by reiterating this: there is always a balance to be struck between efficiently providing patients and health consumers with therapeutic products that will ameliorate their suffering, and managing the risks inherent in bringing new goods, particularly drugs, to market. Labor will always work to improve outcomes for patients. We will be closely watching the effect of this legislation and the impact it has on health consumers in coming years.

Greg Hunt (Flinders, Liberal Party, Minister for Health) Share this | Link to this | Hansard source

I want to thank all of the members of the House who have spoken on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. In particular I want to note the bipartisan support for this measure—and we appreciate the cooperation of the opposition—and to acknowledge the work of the officials within the Department of Health, including the work of the head of the Therapeutic Goods Administration, Professor John Skerritt, who is in the chamber at this moment. The measures contained in this bill will support the implementation of eight key recommendations of the Expert Review of Medicines and Medical Devices Regulation. These recommendations aim in particular to enable faster access to important new medicines and medical devices for Australian patients, as well as to streamline administration and reduce regulatory burden in several areas.

They come at exactly the moment where the government was able to announce price reductions for 1,100 medicines across Australia on the weekend. Those are 1,100 medicines which will be cheaper for Australian families, and eight new medicines which either are being listed or access is being extended to under the Pharmaceutical Benefits Scheme. The TGA and the PBAC operate as two steps in the gateway towards the listing of medicines or, in other cases, devices, where there is a different listing process, but those two pathways begin with the TGA, and only on the weekend we saw the incredible outcomes for the Australian people in the cost of living and better access to medicines.

In that context, in relation to this bill some of the streamlined processes—for example, replacing the need for pre-approval with notifications for some variations to products that do not affect product safety—will lower costs to industry and, potentially, consumers through decreased TGA fees. The bill will also enable regulations to be made to allow Australian companies to undertake conformity assessments of medical devices, make it easier for doctors to prescribe to patients unapproved products with a history of safe use, give sponsors of complementary medicines review and appeal rights when decisions are made about proposed new ingredients for listed complementary medicines, and support accelerated access to certain vital and life-saving prescription medicines, which may be available to Australian patients up to three months faster than under the current framework. Three months can make a fundamental difference to either the health of a patient or their prospects going forward.

The reforms in the review cover far-reaching aspects of the regulatory framework for therapeutic goods, including prescription medicines, complementary medicines, medical devices, advertising and enhanced post-market monitoring. In order to realise the benefits to industry and consumers as soon as practicable, the government has committed to a staged approach to implementation over 18 to 24 months, with a second bill covering further reforms expected to be introduced in the 2017 winter sittings. I thank all of those involved, particularly the TGA, officials within the department, and the industry itself. I want to compliment those involved in the medical devices sector, but in particular Medicines Australia and the work of their chair and CEO. They have played a very important role in all of their dealings with government. I thank them, I commend them and I commend this bill to the House.

Question agreed to.

Bill read a second time.