Parliamentary inquiry into novel medical technologies and new drugs

The House of Representatives Standing Committee on Health, Aged Care and Sport has commenced an inquiry into approval processes for new drugs and novel medical technologies in Australia.

Medical Technology Association of Australia (MTAA) CEO, Ian Burgess, said “Ensuring all Australians have access to the latest in MedTech innovation has long been a priority for MTAA. Throughout COVID-19, MTAA worked with its partners in the Research and Development TaskForce (RDTF) to ensure clinical trials could continue and Australians had access to essential MedTech innovations. We welcome the Minister for Health’s referral of this important issue to an inquiry and look forward to making a submission.”

ARCS Australia CEO, Dr Shanny Dyer, said “ARCS Australia welcomes the inquiry announced on 18 August. We have just finalised a position statement that addresses the hurdles and barriers for delivering clinical trials in Australia. This statement was supported by 15 of Australia’s leading Clinical Research Organisations. It sets out what Australia needs to build a strong clinical research sector. Most importantly, the statement addresses the use of telehealth and other digital approaches for the delivery of clinical trials and recommends that these systems be imbedded as a national platform that will enable us to continue the delivery of clinical trials during COVID and beyond. This will have the benefit of maintaining the delivery of life saving therapies to patients and bring additional economic benefits to Australia through an expansion of trial activity as a result of Australia’s management of health services during the pandemic.”

The Chair of the Committee for the Parliamentary inquiry, Mr Trent Zimmerman MP, said that the Committee looks forward to receiving information on how Australia can continue to be well positioned to access new drugs and novel medical technologies, with a particular focus on access to the treatment of rare diseases and conditions where there is high and unmet clinical need.

Mr Zimmerman commented that “the Committee will examine processes in place for establishing and conducting clinical trials in improving the lives of patients and increasing investment in Australia’s research and development sector.

The Committee will also look at options to incentivise earlier application for approval by sponsors of new drugs and novel medical technologies, without compromising patient safety or the assessment of cost-effectiveness.

We’re looking forward to hearing from the public, health professionals and organisations, pharmaceutical companies and other interested parties on how Australia could position itself best on providing access to new drugs and novel medical technologies for all Australians now and into the future.”

Terms of Reference

This inquiry will consider the following topics so that Australia continues to be well positioned to access new drugs and novel medical technologies in a timely manner and respond to emerging global trends:

1. The range of new drugs and emerging novel medical technologies in development in Australia and globally, including areas of innovation where there is an interface between drugs and novel therapies;
2. Incentives to research, develop and commercialise new drugs and novel medical technologies for conditions where there is an unmet need, in particular orphan, personalised drugs and off-patent that could be repurposed and used to treat new conditions;
3. Measures that could make Australia a more attractive location for clinical trials for new drugs and novel medical technologies; and
4. Without compromising the assessment of safety, quality, efficacy or cost-effectiveness, whether the approval process for new drugs and novel medical technologies, could be made more efficient, including through greater use of international approval processes, greater alignment of registration and reimbursement processes or post market assessment.

Submissions from interested individuals and organisations are invited by Tuesday 13 October.