Health, Aged Care and Sport Committee Report

  • November 25, 2021

On behalf of the Standing Committee on Health, Aged Care and Sport, I present the committee’s report entitled The new frontier—delivering better health for all Australians: inquiry into approval processes for new drugs and novel medical technologies in Australia, together with the minutes of proceedings.

The report is quite a weighty tome. Over the past 18 months, many Australians have observed with awe and admiration the incredible work of medical scientists in finding vaccines and new treatments to a virus that has taken so many lives or impacted the health of millions of people around the world. Many of the innovations and medical understandings developed during the COVID-19 pandemic will have long-term benefits for health treatments for other conditions beyond COVID-19. These innovations reflect the new frontier of medicine, which is giving many hope for better treatments and technologies for conditions ranging from cancers to rare diseases. At its forefront is the development of personalised, or precision, medicine, which is being delivered as our understanding of fields like genomics grows. This report examines the opportunities to deliver better health care for Australians through our regulatory and health technology assessment process for both medicines and technologies.

Australia has long prided itself on having one of the world’s best health systems. By any measure, we do. However, no nation and no health system can rest on its laurels. With innovation happening at a fast pace, governments at both the state and federal level have a duty to ensure that Australians continue to have access quickly to medicines and medical technologies and that our health systems facilitate that outcome rather than hinder it. Medical innovation has grown exponentially in recent years, and pharmaceutical and medtech companies are eager to bring new medicines and devices to market as efficiently as possible. The committee heard from clinical experts and patient groups and their families, who urged us to support a more flexible system to provide for timely access to the latest medicines, devices and treatments.

One of the challenges facing the existing system is the trend towards delivering precision medicine to patients. Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variabilities in genes, environment and lifestyle for each and every person. This offers great hope for patients with a broad spectrum of conditions and diseases, including patients with rare diseases. However, these developments were not envisaged when the current regulatory and reimbursement system was designed and legislated many years ago. The committee recommends the creation of a centre for precision medicine and rare disease within the Department of Health to provide advice on research priorities, education and training for clinicians and patients and the development of a comprehensive horizon scanning unit for new medicines and novel medical technologies. The committee also recommends that a new pathway for cell and gene therapy be established to simplify the health technology assessment processes.

The committee heard from patients and their families about the need for more patient involvement in the approvals decision-making process for new drugs and novel medical technologies. Patients do have a crucial perspective on what treatments work best for them, including important lifestyle benefits, but this has traditionally not been given enough attention within the regulatory system. The committee recommends reforms that will strengthen the central role that patients should have in that assessment process. The committee heard that patients and clinicians were frustrated that some medicines and technologies are available overseas but not yet in Australia, with companies seemingly deciding not to sell their products in Australia for commercial reasons. This is a particular issue that arises for orphan drugs and drugs for rare diseases. The committee therefore recommends changes to encourage companies to enter the Australian market with their products and technologies. This includes changes to the fee structure for applications to the health technology process, particularly for orphan drugs and smaller companies, including Australian startups. The approval processes for new medicines and novel medical technologies are very complex, and this report discusses different ways to streamline them to provide better and faster patient access to treatments. One example of this is the Life Saving Drugs Program for treatments for very rare diseases, which, despite urgent patient need, currently requires a lengthy two-step application process. The committee recommends this process be streamlined into a one-step process.

Clinical trials are another area where Australia has considerably strong comparative advantages. However, the committee has recommended changes to streamline the system even further to ensure Australia is an attractive location for clinical trials. This includes the immediate harmonisation of ethics and governance approvals into one online platform and the establishment of a national registry.

It was clear to the committee that there was a great deal of momentum behind the push to improve the regulatory and reimbursement system—not just a general desire for change but a wealth of ideas for reform and a willingness to make the efforts and compromises necessary to implement them. The committee hopes that this report catches those ideas and paves the way for the improvements needed to provide Australians with the best possible health care now and into the future. I have only touched on a few of our recommendations today. There are many more that I hope the government considers.

I want to thank everyone who took the time to give evidence to this inquiry—most particularly, all the patients and their families. Their testimony was often moving and exceptionally persuasive. I also want to thank my fellow committee members for their close engagement and their knowledgeable contributions to this inquiry. The health committee is an outstanding committee, and the level of cooperation amongst all its members has been superb. I particularly want to thank my deputy chair, Dr Mike Freelander MP, for his expertise, good judgement and good humour, often at the butt end of my jokes. I also want to particularly acknowledge the role of the two supplementary members that we had for this inquiry, who brought their own expertise: the member for Higgins and the member for Dobell. Finally, I want to thank our committee secretariat staff, particularly Kate Portus, Rebecca Gordon and Peter Richardson. They have supported our work with exceptional dedication and quality, and occasionally some patience and forbearance.

The new frontier of medicine and technology is an exciting one for the health care we provide as a nation. Acting now to build on our obvious strengths in health will have enduring benefits for all Australians, for this generation and future generations to come. I commend this report to the House.