Submission Health innovation Smarter investment System reform and governance Clinical trials Commercialisation Economic diversification Industry Medicines

Response to the Critical Technologies Discussion Paper: Health

Research Australia 1 April 2021 2021 · Submission

In brief

Research Australia recommended the Government to build local capacity to make medical products, starting with manufacturing for clinical trials and a body modelled on the United States agency BARDA. It also called for simpler commercialisation funding and a target for Australia to become a net exporter of critical medicines by 2035.

Abstract

This submission responds to the Australian Government’s Critical Technologies Discussion Paper, answering four of its nine questions from a health perspective. Research Australia proposes changing ‘Molecular Robotics’ to ‘Medical Robotics’, broadening the gene technology category to include stem cells, mRNA, CRISPR and small RNA products, and adding a category for active pharmaceutical ingredients and other specialised raw materials for medicinal products. On supply chains, it identifies a critical gap in facilities able to manufacture medical products at the scale needed for later-stage clinical trials, using case studies of ROMAR Engineering and Vaxxas, and recommends a Commonwealth-funded feasibility study into one or more such facilities, built with government and private investor consortia. It recommends an Australian equivalent of the United States Biomedical Advanced Research and Development Authority (BARDA) and its Centers for Innovation in Advanced Development and Manufacturing, using the Commonwealth’s role as a major purchaser to support domestic development and manufacture, and cites the Government’s agreement with CSL Seqirus for an $800 million vaccine facility as an ad hoc precedent. On uptake barriers, it maintains that fragmented grant programs, such as separate NHMRC Ideas and Development Grants with an 18-month gap, should be replaced by a single staged, outcome-focused commercialisation pathway, possibly using co-investment models like the Biomedical Translation Fund. Noting that Australia ranked 26th in pharmaceutical exports in 2018 at $2.5 billion against $7.17 billion in imports, it proposes a goal of becoming a net exporter of key critical pharmaceuticals by 2035.