Thursday, 14 May 2020
Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020; Second Reading
I rise to speak on the Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020 and I move the following amendment:
That all words after "That" be omitted with a view to substituting the following words:
"whilst not declining to give the bill a second reading, the House:
(1) notes Australia's substantial reliance on global supply chains for medicines and medical devices;
(2) further notes the supply issues that Australians have experienced during the COVID-19 pandemic, particularly for common medicines; and
(3) calls on the Government to consider stronger domestic supply capabilities as part of Australia's post-COVID-19 response".
This bill makes a number of minor and technical amendments to the Therapeutic Goods Act 1989 which governs the regulation of medicines and medical devices in Australia. The bill includes three main provisions. Schedule 1 amends a number of device related definitions in the act to align them with the European Union framework following recent EU changes. Alignment with the EU was recommended by the 2015 Review of medicines and medical devices regulation. Alignment helps the Therapeutic Goods Administration draw on existing EU assessments when considering whether a device is safe and effective for use in Australia.
Schedule 2 allows the secretary to provide early advice to medicine sponsors about information that may be needed for TGA approval. The TGA already publishes guidance to assist sponsors, but this does not cover every possible scenario. As a result, some sponsors currently spend time and resources developing evidence that is not required or fail to provide required evidence, delaying access to medicines. The bill allows sponsors to request guidance before an application is submitted.
Schedule 9 introduces a data protection regime for assessed listed medicines and complementary medicines that are listed in the register but being assessed for efficacy before they are given marketing approval. This will provide five years protection for clinical trial information that a sponsor submits in support of an application where that information is not otherwise available. This mirrors the existing regime for innovative prescription medicines.
The bill also includes a number of more minor provisions, including schedule 6, which removes an unintended barrier to addressing medicine shortages. Under the Therapeutic Goods Amendment Act 2018, sponsors of higher-risk medicines are required to report shortages or permanent discontinuation of supply. However, it is an offence for the sponsor to claim that they can arrange a supply of an alternative unapproved therapeutic good. This bill removes that offence.
Labor supports this bill because we support Australians having access to medicines and therapeutic devices in a timely, affordable and, importantly, safe way. Long before I worked in this place, I knew being sick in a wealthy country like Australia shouldn't mean you struggle to keep a roof over your head. As a pharmacy student in 1996, when I studied drug legislation, it was obvious this was a complex area. But what struck me then and now is just how important this is. As the only pharmacist in this parliament, and having first registered in 1998, I'm determined to use my role as an MP to help in any way I can to make sure medicines are affordable and accessible no matter where you were born or where you live or grow old.
We are lucky in that, by and large, medicines in Australia are affordable because of the PBS. But this isn't universal. We shouldn't underestimate the impact of health costs, particularly for people living with chronic conditions. The cost to individuals living with asthma, diabetes or heart disease and using multiple medications has a big impact on household budgets. As a pharmacist, I've been handed a bundle of prescriptions by a parent after a family visit to a GP and asked, 'Which is the most important script to fill?' or 'Which one could be skipped or delayed?' I've been asked by a mum, 'Could an antibiotic mixture could be shared between two children?' This is even more distressing when, as the COVID-19 situation continues to unfold, common medicines aren't available.
Labor supports the measures in this bill to remove barriers to addressing shortages of medicines, but, clearly, much more needs to be done. Pharmacists, as I've mentioned, are familiar with medicine shortages. They experience this day to day and they experienced it even before COVID-19. I've explained some of my firsthand experience dealing with shortages in a community pharmacy. This has also happened when I worked at our local hospital as a specialist mental health pharmacist, accessing medicines through the TGA Special Access Scheme for patients at high risk if they had to discontinue or switch medications on which they'd been stabilised; as a chief pharmacist and member of a hospital drug and therapeutics committee; and now as a local MP hearing the problems faced accessing medicines in this crisis.
Medicine and medical device shortages represent a growing and potentially life-threatening risk. This risk is real as we face COVID-19. According to the Pharmaceutical Society of Australia, for patients and carers, medicine shortages can be inconvenient, stressful and time-consuming and have cost implications. Depending on the nature and duration of a shortage, it can also negatively impact on a person's health and quality of life. The Pharmacy Guild emphasised this and that it's often worse for people living in regional and remote Australia. It can cause particular difficulties for people living in remote and regional areas, sometimes requiring them to travel long distances to obtain necessary medicines.
In the first two weeks of March, as we faced COVID-19, demand for medicines rose sharply, resulting in pharmacies and wholesalers reporting numerous outages of common medicines.