AAMRI Submission to the Inquiry into approval processes for new drugs and novel medical technologies in Australia

AAMRI Submission to the Inquiry into approval processes for new drugs and novel medical technologies in Australia

4th November, 2020

The House of Representatives Standing Committee on Health, Aged Care and Sport is conducting an Inquiry into approval processes for new drugs and novel medical technologies. There is a particular focus on those for the treatment of rare diseases and conditions where there is high and unmet clinical need.

This inquiry will consider four 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.

In the submission, AAMRI has put forward the following recommendations in response to the terms of reference:

Recommendation 1.

Invest in national capabilities to support all stages of the R&D pipeline and address funding gaps. This approach will maximise Australian Government investment in research and early-stage translation by ensuring that discoveries have a supported pathway to industry investment. These investments should include:

  • Establishing a broad scope funding pathway for non-commercial translational research with great potential for returning health benefits. This would build on the work already being undertaken by funding schemes such as the MRFF Clinical Trials Initiative.
  • Establishing national centres with capabilities in drug development downstream from screening/discovery up to investigational new drugs.
  • Establishing a central resource to connect research, investors and potential development partners. Bringing these partners together will increase opportunities to create a value proposition for a combination product and better enable and accelerate such projects towards a new therapeutic.

Recommendation 2.

Prioritise and resource existing national efforts to establish a “clinical trials front door” by mandating a single streamlined approval process for ethics and establishing harmonised and efficient governance approvals for clinical trials.

Recommendation 3.

Revise approval processes to reduce existing barriers by:

  • Enabling ongoing use of virtual clinical trials through telehealth, teletrials and delivery of trial materials to participants including assessments, which have been helping to bring the trial to the patient. These measures have worked very effectively during the COVID-19 pandemic and should be continued to broaden inclusion in trials from remote and regional participants, and to encourage interstate trial participation through Primary sites and cluster models.
  • To shorten review timeframes for conditional approval, establish an accelerated regulatory pathway through the Therapeutic Goods Administration (TGA) for drugs and devices that recognises previous approvals from international regulatory bodies.
  • Establishing a progressive approval pathway for rare diseases that allows use of real-world registry data to support use of new treatments where no treatment has previously been approved.
  • Establishing a standard, routine approval pathway for molecular indications of drugs and treatments. This would exist alongside the current pathway for therapeutics with disease indications.
  • Providing regulatory incentives for sponsors of new drugs that create an accelerated pathway for safe use in hard to reach populations such as granting patent extensions of 6-12 months and providing vouchers to sponsors that grant accelerated approval.

The full submission can be downloaded below.