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

I want to thank all of those who have spoken on the Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020. The member for Bruce made important points about antidepressants, and I have referred that matter to the TGA, and I also look forward to receiving the response. It's about making sure that people have access to medicines that can help protect them and help them through what can be the most difficult of times in a way that is safe and not merely a default which avoids the necessary therapy, cognitive behavioural support and mental health support necessary to deal with so many cases. It's about getting the appropriate treatment for the appropriate condition.

I also want to thank the member for Robertson. She, in particular, has been a great advocate for the Pharmaceutical Benefits Scheme. As she noted, over 2,400 medicines—approximately one per day—have been listed on the PBS during our time in government. They're medicines such as Avastin and Tecentriq. They're medicines for spinal muscular atrophy. They're life-saving medicines for conditions. These have been immensely important. She mentioned Avastin, which would have cost up to $31,000 per treatment over the course of time. It's now available for $6.60. We will continue to list all of the medicines that the PBAC approves.

One of the things which I do want to highlight to the House is that from time to time there will be companies that seek to astroturf. Astroturfing is where a company refuses to abide by the legal requirements and conditions set out by the PBAC. They will attempt to support a patient group with funds to try to pressure the government to bypass the legal requirements. The government cannot bypass the legal requirements. One such case that I do want to call out is the improper practice of Eli Lilly. Their practice has been improper and inappropriate. They are denying patients access to Emgality, a medicine for migraines. This is Migraine Awareness Week. Their behaviour is improper and inappropriate, and they're seeking to avoid the legal requirements. Today I am calling on that company to stop denying patients access to this medicine and to meet the legal requirements, which are mandatory. They are mandatory because of safety. They are mandatory because of efficacy. On this day, this company must abide by the legal requirements and should stop their practice of denying their patients access to a medicine which has been approved by the PBAC but for which they refuse to meet the legal requirements. It is, in my view, unethical and inappropriate and we are calling it out.

Against that background, this is landmark legislation. This bill amends the Therapeutic Goods Act to implement a range of fundamental measures to support the health and wellbeing of Australians. In particular, the bill introduces measures to improve access to therapeutic goods for Australians, encourage innovations, reduce regulatory burden and enhance patient safety by removing barriers to efforts to alleviate medicine shortages.

In relation to improving access to therapeutic goods, the bill amends a number of medical device definitions to more closely align Australia's regulatory framework for devices with the European Union framework. As most devices supplied in Australia are manufactured overseas, reducing differences between the two frameworks is designed to minimise delays in device sponsors and manufacturers seeking marketing approval in Australia after European approval.

The bill enables the secretary to provide early scientific advice to sponsors of registrable medicines, mainly prescriptions and over-the-counter medicines, about prescribed aspects of the medicines' safety, quality or efficacy—exactly the things which I referenced in relation to the work of the PBAC in approving medicines for the PBS—to assist sponsors to understand the level of information needed to support a successful application for marketing approval. This measure will reduce delays in access to new medicines that stem from industry uncertainty about aspects of supporting information for such products, particularly for generic medicines in relation to bioequivalence studies. The advice will guide sponsors and help them reduce the incidence of rejections and the time and cost of developing evidence that is not needed.

The bill also removes a barrier for promising new medicines to access the new provisional registration pathway, which was introduced in 2018 to provide access to medicines that provide a major therapeutic advance over existing treatment options for very serious conditions. Other measures in the bill address issues of delay and interruption for operators of clinical trials who need to make variations to the terms of their approvals and improve flexibility for authorised prescribers seeking to supply unapproved goods to their patients, and the measures encourage investment through the introduction of a targeted data protection regime for the clinical trial data for assessed listed medicines.

It is my view that, in addition to the legislative amendments, we have a unique opportunity in Australia. Australians have done it hard through the course of the COVID-19 pandemic, but they have been magnificent. As a result of those successes in helping to flatten the curve, not only have we saved lives and protected lives in Australia but we have still further enhanced the standing of Australia's medical system, health system and medical research system. As a consequence, there is a unique opportunity for Australia to further advance our clinical trial capacity. The world wishes to practise clinical trials in Australia whenever possible. So we are seeking to work with the states on a one-stop-shop for clinical trial approvals. If we can expedite that pathway, we can give more Australians earlier access to breakthrough new therapeutic medicines, build jobs in Australia and build the medical sector still further.

The bill also enhances patient safety by removing a criminal offence that has been the subject of concern that it may be a disincentive to sponsor some potential alternative products to a medicine that is in shortage by identifying if they are able to arrange for the supply of their products to help alleviate the effects of the shortage. It is part of the general process of making drugs, devices, medicines, therapeutic procedures and implantables available to more Australians at an earlier time. It wouldn't have happened without the work of the TGA, the department, the Medical Technology Association of Australia, Medicines Australia and my office. I particularly want to thank my medicines adviser, Sam Develin; my budget adviser, Belinda McEniery; and my legislative adviser, Chantal D'argaville. Altogether, they've played a very important role. I thank the members for their contribution to the debate on this bill, and I commend the bill to the House.

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