AusBiotech has welcomed The New Frontier – Delivering better health for all Australians – the final report delivered by the Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia.
AusBiotech was one of more than 200 submitters that enthusiastically engaged with the Parliamentary Committee, and through written submission and in-person presentation it highlighted the long-term and stable biotech policy incentives needed to support and sustain R&D for treating rare diseases and conditions, where there is high and unmet clinical need.
Keeping Australian patients front-of-mind, this 400-page report examines opportunities to deliver better health care for Australians through our regulatory and reimbursement processes for medicines and technologies. The 31 Recommendations and additional and numerous sub-recommendations span the pipeline of development, and covers the ecosystem of stakeholders involved in getting medicines and technologies to patients.
AusBiotech CEO, Lorraine Chiroiu, said, “This report includes key recommendations on processes that industry has been challenged by for many years, and offers an opportunity to both reduce the existing red tape and to roll out the red carpet as we prepare for new technologies that are on Australia’s horizon.”
AusBiotech proudly advocates on behalf of our national biotech sector; it is pleased to see many of the issues that are included in the key recommendations, having long-advocated for them. These include:
- Protecting existing and designing new tax incentives that create end-to-end motivation, and bridge over extensive investments. Keeping the benefits of home grown, often publicly funded IP in Australia will enable Australia to economically and societally benefit and will also incentivise the associated manufacturing to stay here and boost our sovereign capability
- Supporting new therapies to address Antimicrobial Resistance by reviewing and assessing existing funding, and considering implementation of a national reimbursement system
- Supporting equitable access to blood products
- Valuable initiatives that position Australia as the premier destination for international clinical trials, including e-consents, a National One Stop Shop, and a National Front Door.
- International harmonisation of regulatory guidelines and priority tracks around approvals, especially in emerging areas
- Increasing the TGA’s education campaigns, including health literacy and building a better understanding of the benefits and impacts of emerging medicines and technologies for patients, governments and industry. AusBiotech believes the TGA should be appropriately resourced through non industry-recovered funding to accomplish this necessary activity.
The significance of the biotech sector, what it has delivered (particularly over the past 18 months), and its potential for the future was noted, with The New Frontier unanimously adopted by the entire bipartisan Committee. The report has been tabled, and is under consideration by the Federal Government.
Tackling the regulatory and reimbursement challenges in the sector, many of the Parliamentary Inquiry’s recommendations also align to the draft Biotechnology Blueprint, industry’s decadal strategy that has been led by AusBiotech, and designed by industry. The Biotechnology Blueprint offers a pathway to shift the horizon of possibility, and reach industry’s ambitions for the coming decade. The draft strategy is an opportunity to speak as one voice and includes key priorities for the ecosystem to work together to improve our business environment and deliver better results for the patients and the sector. The Biotechnology Blueprint is currently open for consultation and the sector is warmly encouraged to submit its feedback.
Read The New Frontier – Delivering better health for all Australians report here.