Summary of this Part

This Part provides for:
  • review of decisions by the GTR and the Administrative Appeals Tribunal;
  • procedures in relation to the protection of confidential commercial information;
  • how the state of mind of a body corporate (or a person) shall be established in relation to the prosecution of an offence under the legislation;
  • transitional provisions describing how existing approvals by the Genetic Manipulation Advisory Committee will be treated under the new legislation; and
  • the making of regulations to support the Bill once it becomes law.

Key provisions in this Part and major changes as a result of consultation on the draft Bill

Review of decisions (Division 2)

During consultations, very polarised views were expressed on the issue of review of decisions. Some people felt that ‘merits’ review by the Administrative Appeals Tribunal (AAT) under the Administrative Appeals Tribunal Act 1975 (Cth) should only be open to people directly affected by a licence decision (such as the applicant or licence holder) and others felt that this should be extended to third parties.

In drafting the legislation, we were conscious of the need to ensure transparency and accountability of the GTR, while at the same time not encouraging extensive use by third parties of a right of review that could be costly and greatly diminish certainty of decision making for people or organisations who have been granted a licence.

The effect of Division 2 of the Bill is that certain persons may seek review of decisions made under the legislation. Essentially, those people would include:
  • licence applicants and licence holders;
  • applicants for certification and holders of certification (for example, universities or companies who have sought certification to a certain containment level of facilities owned by them); and
  • applicants for accreditation and holders of accreditation (for example, universities and institutions who have sought accreditation, recognising that they have established and maintained an Institutional Biosafety Committee within their institution).
If the relevant decision has been made by a delegate of the GTR (for example, one of the senior staff members of the GTR) the person seeking a review of the decision would have to apply to the GTR for an initial review of the decision. The GTR would look closely at the delegate’s decision and could substitute his/her decision where appropriate.

If the GTR made the decision personally (or if a person has sought review by the GTR and seeks further review of the decision) an application for further review may be made to the AAT. The AAT undertakes merit reviews of administrative decisions.

The AAT may:
  • stay the operation or implementation of a decision until the AAT hearing;
  • affirm the decision made by the decision maker;
  • vary the decision;
  • set aside the decision;
  • substitute its own decision; or
  • remit the matter to the original decision maker with directions or recommendations for re-making the decision.
Review by the Federal Court under the Administrative Decisions Judicial Review Act 1977 (Cth) (ADJR Act)

Unlike the AAT, which examines the ‘merits’ of the case, under the ADJR Act the Federal Court examines questions of law in relation to administrative decisions, in particular the process by which decisions have been made.

Any person “aggrieved” by a decision made under the Gene Technology Act (once proclaimed) will be able to apply to the Federal Court for review of questions of law in relation to the making of the decision. The legislation will not affect the ability of anyone to seek review under the Administrative Decisions Judicial Review Act (ADJR). Anyone wishing to have a decision reviewed by the Federal Court under the ADJR Act must establish “standing” or a “special interest” as required by the Federal Court. While this is judged on a case-by- case basis, the general position is that an applicant must be able to show an interest above and beyond that of ordinary members of the public.

Confidential commercial information (Division 3)

During consultations, we received a number of submissions about the types of information that should be made available by the GTR, and the types of information that should be protected as confidential commercial information. We heard that:
  • as a general principle the public should have a right to information submitted as part of an application for a licence, and that the relatively free availability of information would help to ensure that the GTR’s decision-making remained appropriate, transparent and accountable;
  • the general public should have ready access to the same types of information that they could access through an application under the Freedom of Information Act; and
  • there should be appropriate protection for information which is commercially sensitive, and this could best be guaranteed by an assessment of confidential information being made by the GTR on a case-by-case basis. Researchers also made the point that, while details about work being conducted in universities may not be commercially confidential, the intellectual value of research could be greatly diminished if full details were made publicly available.
On the basis of these comments, we have attempted to strike a balance between the legitimate protection of confidential information and the need for a high level of transparency, openness and accountability of decision-making by the GTR.

Division 3 of this Part sets out the process for establishing the confidentiality of certain information.

A person may apply to the GTR for a declaration that certain information is confidential commercial information. The GTR assesses the application and may declare the information to be confidential commercial information if he/she is satisfied that the information:
  • is a trade secret;
  • has commercial or other value which could be destroyed or diminished if the information were disclosed; or
  • is about the commercial or financial affairs of a person, organisation or undertaking that if disclosed could unreasonably affect the person, organisation or undertaking.
The GTR may choose not to declare information to be confidential commercial information if he/she is satisfied that the public interest in the disclosure outweighs the prejudice that the disclosure may cause to the person.

If the GTR is satisfied that the information falls into one of the categories described above, the GTR may issue a declaration that the information is confidential commercial information.

The effect of a declaration is that the information is not made publicly available by the GTR. For example, the confidential information would not be made available in response to a public request for an application, and the information would also not be placed on the Record of GMOs and GM Product dealings.

If the GTR refuses to declare that information is confidential commercial information, the applicant has the opportunity to withdraw the application or seek review of the decision before the information is released publicly.

Conduct by directors, employees and agents (Division 4)

This Division contains the formal provisions that establish how the state of mind of a body corporate (or a person) must be established for the prosecution of an offence under the legislation.

For example, if it is necessary to show that a licence holder (being a body corporate) engaged in certain activities (such as unlicensed dealings with GMOs), it is sufficient to show that the conduct was undertaken by a director, employee or agent of the body corporate, and that the director, employee or agent had the requisite knowledge of what they were doing.

Transitional provisions (Division 5)

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This Division describes “transitional arrangements” in relation to dealings with GMOs approved prior to the commencement of the Bill. The effect of the transitional arrangements is that if a dealing with a GMO received advice to proceed from the Genetic Manipulation Advisory Committee before the commencement of the licensing provisions of this Bill, then that dealing is deemed to be licensed under the Gene Technology Bill. The licence is taken to be subject to any conditions imposed by the Genetic Manipulation Advisory Committee‘s advice to proceed. During the transitional period, all of the other provisions in the legislation (including those relating to the imposition of additional conditions, reporting, monitoring and enforcement) also apply to the ‘deemed’ licences.

The ‘deemed’ licence continues to be in force until the period ending at the earliest of the following times: the time the advice to proceed expires, at the end of two years beginning when the Bill received Royal Assent, or when the licence is cancelled or surrendered.

If, at the time when the licence ceased to be in force, the licence holder wished to continue the dealings with the GMO, the licence holder would need to apply to the GTR for another licence.

During consultations on the draft Bill there was strong support for including transitional provisions in the legislation. Transitional provisions:
  • avoid the need for the GTR to re-assess hundreds of existing approvals as soon as the legislation takes effect;
  • minimise costs to industry associated with having to re-apply for assessment having already undergone an assessment by GMAC;
  • ensure that anyone undertaking work assessed by GMAC must also comply with the new statutory conditions of licence and be subject to the monitoring and enforcement provisions of the legislation; and
  • ensure that the GTR will review and re-assess all approvals granted by GMAC within a two year period.

Other (Division 6)

This Division enables the Governor-General to make regulations to support the operation of the Bill. More information about the proposed Regulations is included in the Chapter 7 titled “Commonwealth Gene Technology Regulations”.

For a clause by clause explanation of this Part please refer the Explanatory Memorandum to the Gene Technology Bill 2000