Embryonic stem-cell research and new biotechology laws

Exempt Dealings

An organisation may deal with a GMO if the dealing is specifically exempt under the regulations to the GTA. Generally speaking, exempt dealings are those that do not involve the intentional release of a GMO into the environment and fall within certain Australian standards for physical containment.

Dealings on the GMO Register

As mentioned above, any type of dealing with a GMO recorded on the GMO Register is permitted under the GTA. The GTR may add a dealing to the Register if:

• the dealing is subject to a GMO licence; and
• it is a Genetically Modified Product and is a GMO by virtue of regulations made.

This means that the GTR has the power to review any dealings with GMO’s that are already subject to a licence. It may then, if it considers appropriate, add the dealings to the GMO Register. The GTR can only do so if it satisfied that the risks posed by the dealings in respect of a particular GMO are minimal and that the person who is currently undertaking the dealing does not have to be covered by a GMO licence in order to protect the health and safety of the public.

Any organisation that holds a licence for a particular period of time may apply to the GTR (or the GTR may in fact decide itself) to review the licence and remove the requirement for a licence in respect of that dealing by entering the dealing on the GMO Register.

Accreditation of organisations and institutional biosafety committment under the gene technology laws

Organisations must now apply to the GTR for accreditation before they can undertake any form of GMO dealing. Prior to any such application being approved by the GTR, the organisation must demonstrate to the GTR that:

• it has set up or has access to an Institutional Bio-safety Committee ("IBC");
• it will meet the requirements under the GTA and GTA Regulations;
• the constitution of the relevant IBC the required standard of compliance expected of an organisation dealing with GMOs; and
• the organisation has sufficiently indemnified the members of the relevant IBC

Some organisations may automatically be accredited under various transitional provisions contained in the GTA. Accordingly, organisations should check whether or not they have received any notification of accreditation from either GMAC or the GTR.

An organisation that has already secured accreditation under the GTA transitional provisions will also need to check the period of accreditation granted to it. Accreditation under the transitional provisions of the GTA will usually expire, at the very latest, 2 years from the commencement of the GTA.

Conclusion

Organisations conducting genetic research, such as those dealing with human embryonic stem-cells, must remain up to date with developments in the legal and political arena. Due to large international commercial focus on the biotech industry, the Federal Government needs to delicately balance the commercial, ethical and moral interests and principles that underpin this contentious debate.