AusBiotech has responded to changes proposed by the Office of the Gene Technology Regulator (OGTR) to the Gene Technology Scheme that seek to modernise and future-proof the risk-management framework.
An enhanced risk-tiered model was recommended as suitable for all regulated communities and sectors in Australia and to ensure the Scheme remains flexible, fit for purpose and futureproof. It would reduce the cost of regulation and enhance the competitiveness of the Australian biotech industry, without compromising the object of the Gene Technology Act. This would prove critical for both agricultural and medical research and for Australia in general, as this would ensure the benefits from new innovations reach Australian and global communities.
The early consideration of how a framework that was originally designed on biotech’s agricultural application could accommodate emerging gene technology fields, such as gene therapies, that do not fit into the current system, was welcomed by AusBiotech.
The submission highlighted that work needed to build on the progress to date. It is important that the proposed changes are effective and do not present unnecessary barriers to the progress of biotech research and development, including clinical trials, which contribute to the wellbeing of the community and the environment.
The proposed changes seek to: update existing definitions in the Gene Technology Act to clarify the scope of regulation in light of on-going technological advances; introduce a new risk-tiering framework that ensures regulation remains commensurate with risk; and reduce regulatory burden through streamlining processes and current regulatory requirements, where appropriate.
Critically, for medicines, AusBiotech recommended that any developments undertaken must be done in coordination with TGA requirements. The TGA is globally-recognised, with well-established processes and regulations governing these activities for safety and efficacy in Australia. Leveraging required and existing risk management measures would reduce overlap on applications and thereby improve review timeliness, and reduce unnecessary duplication of effort and regulatory burden.
As the nation’s peak industry body, AusBiotech holds a unique position as the voice of industry in both agritech and emerging medical developments, such as regenerative medicine. AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian industry.
The Final Report on the Third Review of the Scheme was released in October 2018 and included 27 recommendations. These proposed changes addressed four of the 27 recommendations. Stakeholder feedback on this consultation will inform the development of a Decision Regulatory Impact Statement, which will underpin legislative changes to give effect to Review recommendations.
AusBiotech has actively engaged on consultations on the Scheme throughout its Third Review and seeks to build on the strong work accomplished to date while supporting its ability to prepare for Australia’s gene technology future.