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News & Trends - Pharmaceuticals

Advancing patient-centric regulatory decisions for emerging health technologies: Dr Mike Freelander, Prof John Skerritt, and Rare Voices Australia advocate for a new approach

Health Industry Hub | June 7, 2023 |

Pharma News: In a thought-provoking plenary session at the ARCS Australia conference yesterday, experts convened to discuss the pressing need for a new approach to regulatory decisions concerning emerging health technologies.

The panel, chaired by Dr Megan Bohensky, Head of Market Access, APAC at BeiGene, included Adjunct Professor John Skerritt, former Deputy Secretary of the Health Products Regulation Group, Department of Health; Dr Mike Freelander, Federal Member for Macarthur, Australian Labor Party, and Chair of the Standing Committee on Health, Aged Care, and Sport; and Nicole Millis, CEO of Rare Voices Australia. The session shed light on the current regulatory barriers and the importance of ensuring better patient outcomes through a patient-centric approach.

During the Q&A session, the audience turned their attention to Professor Skerritt, seeking his insights on the lessons the current Health Technology Assessment (HTA) review could learn from the Medical Device Review (MDR) process. He responded by highlighting the importance of embracing best practices from around the world. He urged participants in the HTA review to maintain an open mind and learn from the successful systems implemented in other countries.

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He stated “One thing we tried to do with the MDR was harvest the best international models. We could see some of them didn’t work and some were a bit clunky, but we could modify them and cherry pick the key features. I really encourage those taking part in the HTA review to be curious and open to what’s out there.”

The discussion then moved to the recommendations outlined in the parliamentary report The New Frontier: Delivering better health for all Australians released in 2021 by the House of Representatives Standing Committee on Health, Aged Care and Sport. When asked about the most pressing recommendations, Dr Freelander spoke about the exciting developments in the genomic space and the potential of gene therapies. He stressed the importance of timely access to these innovative therapies and the complexity of assessing their value to society as a whole.

“I think there are some really exciting things happening in the genomic space. We have to be ready for it to make sure patients get early treatment,” he said.

Dr Freelander further expanded on the challenges faced in assessing the value of new health technologies. He shared a personal story of the lengthy approval process for a medical technology aimed at treating his father’s atrial fibrillation. He emphasised the need for “value-for-money, science-based” assessments that consider the broader spectrum of effects on families, communities, and work productivity. He highlighted the complexity of the evolving health technologies and the necessity of keeping pace with advancements.

“Our system has to be able to deal with the complexity of new health technologies. When I started as a junior doctor, people didn’t get into intensive care if they were over 70. The world has changed, and we need to move on,” he said.

Nicole Millis, CEO of Rare Voices Australia, addressed the issue of transparency in regulatory processes and the impact on consumer engagement and input. She called for a holistic approach to transparency, where the entire system works cohesively to increase consumer awareness and understanding.

“Our regulatory system and approval processes are so fragmented that it works against transparency. We need increased transparency to enhance consumer engagement and input. People need to know what’s going on, when, where, and how. If we could approach transparency as a whole system, it would be much more effective,” she stressed.

The session concluded with a question about the government’s appetite for real healthcare reform to create patient-centric outcomes. Dr Freelander expressed optimism, highlighting the government’s willingness to embrace change.

“We have a health minister and a government that is up for change. The budget just passed has been pretty remarkable, and I think we can look forward to some really positive things,” he commented.

Professor Skerritt stressed the importance of Australia remaining an attractive destination for therapies developed overseas so international companies are willing to bring new medicines and medical devices to Australia. He raised concerns about the potential second-tier market if Australia fails to keep up with global advancements.

“Also, we have to have a strong innovation ecosystem locally and the policies need to enable local access when these therapies are developed by Australian companies,” he stressed

Ms Millis added a cautionary note, highlighting the risk of missed opportunities and the impact on Australian patients.

“We have to be aware of that as we look towards the future and embrace change,” she said.

The panel discussion highlighted the importance of a patient-centric focus, transparency, and the need to adapt to the rapidly evolving healthcare landscape to ensure timely access to innovative therapies and health technologies.

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