The Director and CEO of QIMR Berghofer Medical Research Institute, Professor Fabienne Mackay, has told a Federal Parliamentary inquiry the approvals process for new drugs and medical technologies is clunky and needs to be streamlined if the country wants to improve health outcomes for Australians.
The House of Representatives Standing Committee on Health, Aged Care and Sport has held public hearings in Brisbane this week.
The Committee wants to ensure Australia continues to be well positioned to access new drugs and novel medical technologies in a timely manner and in response to emerging global trends.
Professor Mackay said the Institute’s scientists are frustrated that States and Territories have different approvals processes which are limiting research and development.
“We need to take a national approach to ethics approvals to ensure that when new drug and medical technology research has been reviewed and approved by an NHMRC-certified Human Research Ethics Committee, it is accepted across all jurisdictions and doesn’t have to be duplicated in different states and territories,” Professor Mackay said.
“Standardised governance procedures, in particular for clinical trials, should also be implemented across public hospital systems.
“Many of our researchers are trying to progress important new therapies through clinical trials but feel the process is too slow.
“One example is an early phase new immunotherapy clinical trial for kidney, lung and heart-lung transplant patients, led by one of our senior scientists Professor Rajiv Khanna AO. The immunotherapy trial is aimed at protecting patients from complications from their transplants and is being conducted at four sites across Australia. This has required the researchers to attain approvals from two different ethics committees and four site specific governance approvals.
“These reviews can take months and hold off progress. For Australia to be attractive to national and international multisite clinical trials, a cohesive streamlined system is essential.”
Professor Mackay said cutting red tape would bring more efficiency to the medical research sector, attract more investment in the field, and increase jobs and industry-sponsored clinical trials in Australia.
“Standardised and mutually recognised approvals would allow industry sponsors to perform their clinical development programmes faster as more patients could be given fast access to novel therapies in clinical trials performed at multiple clinical centres in the country,” Professor Mackay said.
“More streamlined processes will also give global companies and international collaborators increased confidence in Australian processes and research.
“In addition to the economic benefits this brings, we would also increase our manufacturing sovereignty and decrease our risk of limited supply in a health emergency, such as we have witnessed with COVID-19 vaccines.”
Professor Mackay told the committee that fostering a stronger partnership between the work of the National Health and Medical Research Council and the Therapeutics Goods Administration would allow for a more streamlined approach to ethics and processes.
She congratulated the Federal Government for the new research initiatives announced in last week’s Commonwealth budget but said it was important for research and development tax incentives to continue to be provided to help bolster the sector.
Professor Mackay said as one of Australia’s largest and most successful medical research institutes, QIMR Berghofer was focused on finding cures and clinical responses to improve the health of Queenslanders, Australians and people around the world.
“Many of our researchers conduct clinical trials in an environment of transparent and contemporary ethics, in collaboration with our hospital and health service colleagues, but their research efforts are often slowed and frustrated by the approvals process. We are hopeful this Parliamentary review will help remove the many hurdles they face, so they can focus their energies on what they do best.”