On 14 December 2020, the previously known Legislative and Governance Forum on Gene Technology (now the Gene Technology Ministers Meeting) released a Consultation Regulation Impact Statement (RIS) and Explanatory Paper in relation to Modernising and Future Proofing the National Gene Technology Scheme.
The RIS and Explanatory Paper assess delivering more flexible, streamlined and risk-based processes that future-proof the Scheme, enable efficiencies, and relieve regulatory burden where warranted.
Three potential regulatory options for improving the authorisation pathways for dealing with Genetically Modified Organisms (GMOs) are considered:
- Option A: Status Quo. The current authorisation pathways depend on whether the GMO dealings are “contained” or involve “intentional release of the GMO into the environment”, with the latter having higher oversight.
- Option B: Risk tiering model. The level of oversight is determined entirely by the level of indicative risk, taking into account matters such as the characteristics of the GMO, the type of dealings and whether effective risk management measures are known.
- Option C: Matrix model. The categorisation of GMO dealings in authorisation pathways depends firstly on the nature of the dealing (whether it is “contained”, involves “intentional release of the GMO into the environment”, or involves “clinical trials / medical applications”). After this first categorisation, dealings with GMOs are then classified in different authorisation pathways according to the level of indicative risk.
The Office of Best Practice Regulation considers that the RIS guidelines, as set out in Best Practice Regulation: A Guide for Ministerial Councils and National Standard Setting Bodies (October 2007), have been followed and that the RIS contains an adequate level of analysis, commensurate with the significance of the impacts for a Consultation RIS.