Review of the Gene Technology Act 2000 (Cth) Submission from the Gene Technology Ethics Committee (gtec)

Recommendation 3: The Wider Context of Risk Analysis

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Recommendation 3: The Wider Context of Risk Analysis

GTEC recommends that the wider ethical and social context of risk ought to be recognised and considered in risk analysis.

Re-examine How Ethical Issues are Considered

Given the narrow scope of the GT Act and of what the Regulator can take into account in conducting a risk analysis and making a decision, what is the role of the Gene Technology Ethics Committee (GTEC) (and indeed the Gene Technology Community Consultative Committee (GTCCC)) within this regulatory regime?

At present GTEC does not routinely consider licence applications for any type of dealing (although some sectors of the public perceive otherwise, according to anecdotal evidence. In particular, the GT Act does not provide for consideration of licence applications by GTEC (s 112) in either the specific way this is provided for in relation to GTTAC (GT Act s 101 (b) and 47(4), 50(b), 51 (1)(d), 51(2)(d), 52(3)) or in the more general manner in relation to GTCCC (GT Act, s 107 (aa). However, GTEC notes that consultation on specific applications is possible at the Regulator’s discretion (GT Act, s 53 (1)) and the statute expressly contemplates a ‘stopping of the clock’ for the purposes of GTEC’s consideration should the Regulator exercise that discretion (GT Regulation 8 (2)(e)).
Irrespective of the manner of consultation with GTEC (whether about an individual application or in some other form), the inclusion of GTEC within the regime and the exclusion of ethical matters from what the Regulator can consider when preparing a RARMP or when issuing a licence, could create an anomaly, or a source of tension, within the GT Act. A similar argument could be made in relation to GTCCC. While the GT Act appears to provide for Committee based consideration of ethical issues and community consultation, it does not define the relevance of GTEC or GTCCC to specific licence applications. GTEC recommends that the Review Panel take this into consideration in reviewing the GT Act.
At 4(d) below, GTEC comments further, and at length, on the functions and roles of the statutory advisory committees (also in relation to licence applications). At this point in the submission GTEC’s comments are limited to pointing out the apparent anomaly in the Act and stating some general points about GTEC’s role within the scope of the Act.
GTEC perceives that it has a vital role under the Act advising the Ministerial Council, the Regulator and the OGTR, but also the GTTAC, on ethical issues associated with both the environmental context and possible health effects of gene technology, as part of the wider context of risk analysis that the Regulator is required to consider under the GT Act. This also includes consideration of issues relating to risk communication (on which the interests and expertise of GTEC and the GTCCC might overlap).
The wider context of risk analysis

During the first triennium of the regulatory scheme, GTEC drafted an information paper entitled “Managing Risk Ethically” that considered the ethics of the risk analysis process and made recommendations about how gaps in knowledge, uncertainty, indeterminacy, attention to process and the basis for judgements about acceptable risk might be incorporated more explicitly into risk analysis and thus address some aspects of the wider context of risk analysis. This advice to the Regulator was made available to GTTAC and the OGTR and informed the process of revision of the Risk Analysis Framework (OGTR, 2005, 2nd edition). GTEC considers that while progress has been made on increasing awareness of the wider context of risk analysis, there is scope for further work in this area. This work draws on the expertise of diverse academic fields such as: sociology of risk; risk communication; the design of risk regulation (including precaution); and, public awareness and understanding of science.

This experience of the first triennium of the regulatory scheme informs GTEC’s recommendation that this role of GTEC should be continued and possibly enhanced. The experience also prompts GTEC to suggest that sections 111(5) (composition of GTEC) and 112 (Functions of GTEC) be reviewed to consider the extent to which they authorise GTEC to fully engage with the wider context of risk analysis. GTEC notes that this may not require revision of the GT Act (see also comments made in this submission in relation to Term of Reference 4(b) and Recommendation 11).
GTEC notes that the fact that the theme of the wider context of risk analysis re-emerges throughout this submission indicates its importance as an integral component to the regulatory regime.

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