Australia’s regulatory system for bringing new medicines and devices to patients is regarded as being thorough and robust and is well respected internationally. Australians should be proud of our healthcare system. The Committee heard this from stakeholders, including the pharmaceutical industry, patient advocacy groups and clinicians throughout the inquiry. Many witnesses congratulated the staff working within the Department of Health, including the Therapeutic Goods Administration (TGA) for their professionalism and dedication working on the regulation and reimbursement systems.

Along with this praise came suggestions for improvements to make Australia’s healthcare system even better. A significant challenge for Australia’s regulatory system was to establish more flexible pathways to enable our system to keep pace with medical and technological advances, including precision medicine, that are available now.

The Committee launched this inquiry in August 2020 just months after the declaration that the world was living with the COVID-19 pandemic. At the time that the Committee was reviewing Australia’s regulatory system, the Therapeutic Goods Administration and the Department of Health were fast tracking approval processes for certain drugs to assist with the treatment of COVID-19 patients in Australia. Many submissions noted this unprecedented collaboration with international and Australian regulators, pharmaceutical companies and clinical researchers. It was suggested that lessons could be learned from the pandemic and that our regulatory systems should be streamlined and adapted to cope with the flood of new healthcare innovations coming in the near future.

This report consists of eleven chapters. The final chapter is a list of recommendations:

• Chapter 2 provides a general overview of the recent reviews conducted, and the agreements entered into, by the Australian Government in relation to Australia’s health programs and regulatory frameworks, which have had a bearing on the Committee’s deliberations and subsequent recommendations in this report.
• Chapter 3 presents a high level overview of the regulatory and reimbursement frameworks, the general understanding of how these systems work, and where there are gaps in the system.
• Chapter 4 describes the concept of the ‘patient voice’, how it is currently drawn on in decision-making by Australia’s Department of Health and in overseas models, and what further improvements to government engagement with the patient voice could look like.
• Chapter 5 provides an overview of the Therapeutic Goods Administration including the general themes to have emerged throughout the inquiry, including the regulation of medicines and medical devices, and the financial and technical aspects of its regulation.
• Chapter 6 outlines the Heath Technology Assessment (HTA) system. It discusses the processes of the Pharmaceutical Benefits Advisory Committee. Some of the main issues discussed include: the application process, length of time for review, fees, provisional access and international regulators.
• Chapter 7 explores the Medical Services Advisory Committee, another advisory committee in the HTA system that focuses on medical devices and services. Again, issues of flexibility, length of time for review, resourcing and application processes are discussed, as with its approach to real world evidence. The chapter also looks at the Prostheses List Advisory Committee and the future of the Prostheses List.
• Chapter 8 explores the important issue of rare disease, focussing on Government initiatives, potential HTA alternative pathways, the Life Saving Drugs Program, newborn screening and limitations on data, research and clinical trials.
• Chapter 9 looks at clinical trials in Australia including our regulations and challenges, why we have a competitive advantage, and discusses what is needed for Australia to be ready for a surge in demand for novel medicines and devices in the clinical trial sector.
• Chapter 10 discusses research and development in Australia and what the Australian Government is doing to fund initiatives, what research incentives are available, the need for further and greater horizon scanning, and the regulatory hurdles attached to the repurposing of drugs.