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News & Trends - Pharmaceuticals

BMS joins policy discussions for streamlined regulation of clinical trial landscape

Health Industry Hub | August 29, 2023 |

Pharma News: Australia’s reputation as a leader in research infrastructure and clinical trials is widely acknowledged. Nevertheless, a call for reform has emerged to simplify the current complex regulatory environment, ensuring the country’s continued competitiveness as a destination for clinical trials.

Addressing this need head-on, the Australian Commission on Safety and Quality in Health Care has introduced a novel approach known as the National One Stop Shop (NOSS). Over the course of two days, the halls of Canberra’s Parliament House played host to a thoughtful exchange led by patient advocate Anna Anderson and medical oncologist Professor John Zalcberg from Monash University. Their aim was clear: to underscore the necessity of this fresh model and outline actionable steps for its realisation.

Leah Goodman, Managing Director of BMS Australia and New Zealand, and James McAdam, Associate Director for Government Affairs Policy and Advocacy also joined the discussions.

“Australia has so much advantage when it comes to the quality of our R&D. Our clinical trial capability is immense and it is saddening to see the barriers and disincentives currently in the Australian system lessening Australia’s attractiveness to global choices in country investment. Access to clinical trials improves the economy as well as patient lives. We need stronger Government-Industry partnership to turn this around so the global prisonisation of Australia for investment can be improved,” stated Ms Goodman.

Professor Chris Levi, Immediate Past Chair of Australian Health Research Alliance (AHRA) and James McAdam joined Health Industry Hub earlier this year to discuss the current reforms in the clinical trials ecosystem, key priorities and the challenges that we need to address.

Professor Levi said “It’s an increasing challenge for governments to maintain the investment in health. There’s a need for innovative ways to improve the quality of care and that circles back to the value proposition for clinical trials.”

He pointed to a “relatively unsophisticated understanding” of clinical trials, a lack of skills development and “connection point for all clinical trials enterprises across the country” as key barriers in the current environment.

James and Professor Levi explored the key success factors that will ensure the proposed changes outlined by the Australian Commission on Safety and Quality in Healthcare optimise this landscape.

Ms Goodman added “The importance of this more streamlined and harmonised clinical trials model in Australia cannot be understated. A straightforward and connected framework will support a strong medical research ecosystem locally, so it is reassuring to see bipartisan support from so many Members of Parliament. With around 130 clinical trials currently in progress across the country, BMS Australia is advocating for full implementation as soon as possible to support the delivery of the health benefits to Australians.”

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