Member feedback sought on Inquiry into approval processes for novel medicines and medtech

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AusBiotech calls on its Members for feedback on its response to a new parliamentary inquiry that is considering the “approval processes for new drugs and novel medical technologies in Australia”. The Inquiry has a particular focus on those for the treatment of rare diseases and conditions where there is high and unmet clinical need.

AusBiotech’s draft submission includes commentary on the regulation of regenerative medicines and clinical trials, and policy settings around investment attraction, research funding along with the value creation ‘pipeline’, and the taxation environment.

The House of Representatives Standing Committee on Health, Aged Care and Sport, chaired by Coalition MP Trent Zimmerman, will enquire into and report on approval processes for new medicines and novel medical technologies in Australia, following a referral from the health minister Greg Hunt.

To enable Australia to continue being well-positioned to access new drugs and novel medical technologies in a timely manner, and to respond to emerging global trends, the inquiry is considering:

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.

AusBiotech’s draft response focuses on the emerging area of regenerative medicines. AusBiotech seeks feedback on if there are any other growing areas of demand for medicines or medical technologies that would benefit from improved approval processes.

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.

Our industry is unique, and AusBiotech’s draft submission highlights its particular sensitivity to policy settings around investment attraction, research funding along the value creation ‘pipeline’, and the taxation environment, in the context of global enterprise where Australian comparative advantage is key.

AusBiotech is seeking comments or views on the opportunities and recommendations identified in its submission to incentivise research, development and commercialisation of new drugs and novel medical technologies.

3. Measures that could make Australia a more attractive location for clinical trials for new drugs and novel medical technologies.

AusBiotech recognises the importance of clinical trials in research and development, and lists a number of opportunities and recommendations in support of activity, including growing the national footprint, embedding flexibility, and streamlining and harmonising efforts. Comments and views are sought on its draft recommendations.

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.

Cell and gene therapies are fundamentally different from more common medicinal products as they generally have longer than average development times, more stringent manufacturing requirements, and a limited shelf life for products (sometimes 24 hours). AusBiotech, in consultation with its Regenerative Medicine Advisory Group, has identified a number of opportunities to enhance Australia’s cell and gene therapies regulatory framework.

There are multiple opportunities for Australia to enhance its regulatory framework and therefore, enable the further growth of Australia’s gene and cell therapy sector; the recommendations identified offer a pragmatic approach. AusBiotech seeks further comments and views on the regulatory opportunities identified.

Uniting the life sciences voice, AusBiotech is encouraging comment from Members and is also engaging on the inquiry with Medicines Australia and the Medical Technology Association of Australia.

AusBiotech’s draft submission is available to read in the member-only section of the website.

Feedback can be submitted to Juliana Potulic, Policy and Programmes Manager by Tuesday 6 October.