Approval Processes for New Drugs and Novel Medical Technologies in Australia

This submission to the House of Representatives Standing Committee on Health, Aged Care and Sport responds to its Inquiry into Approval Processes for New Drugs and Novel Medical Technologies in Australia, addressing each term of reference. Research Australia maintains that regulation of products crossing traditional boundaries must be proportionate to risk, and that earlier diagnosis of rare diseases is needed for patients to access clinical trials, recommending expanded capacity under the National Health Genomics Policy Framework and investment in rare disease registries. It contends that funding for new drugs and technologies for unmet needs is a fragmented ‘journey’ rather than a planned process, citing Medical Research Future Fund (MRFF) guidelines for the Rare Cancers, Rare Diseases and Unmet Need clinical trials initiative that favour interventions unlikely to achieve a commercial return. It recommends an end-to-end review of funding programs, revised guidelines that support commercialisation, and recognition of commercialisation strategy costs as legitimate research costs. It welcomes the reversal of proposed changes to the Research and Development Tax Incentive. To make Australia more attractive for clinical trials, it proposes including clinical trials data and the Therapeutic Goods Administration (TGA) in the remit of the National Health Data and Information Standards Committee, making COVID-19 era remote recruitment, consent and administration standard practice, and aligning TGA reporting of trial data and adverse events with international standards such as those of the US Food and Drug Administration.