Embryonic stem-cell research and new biotechology laws

In the last week or so, various "Right to Life" groups have been vigorously lobbying the Federal Government to introduce a ban on certain forms of human embryonic stem-cell research. The possible ban has triggered criticism from various politicians and members of the scientific community.

Stem-cell research could be central to the development of cures to diseases such as diabetes, Parkinson’s and Alzheimer’s, with advances in stem-cell research providing insights into cancer and other genetically affected conditions.

If the Federal Government introduces a ban on certain forms of human embryonic stem-cell research, it will appear to be a contradiction in the Federal Governments’ legislative approach in the biotechnology sector. Recently, the Federal Government passed the Gene Technology Act 2000 ("GTA") which requires organisations dealing with genetically modified organisms ("GMOs") to be accredited by an administrative body known as the Gene Technology Regulator ("GTR").

Previously, genetic research was subject to non-compulsory regulation under the Genetic Manipulation Advisory Committee ("GMAC"). Unlike the old gene technology regulatory framework, the new regime empowers the GTR to impose criminal sanctions upon all organisations that deal with GMOs in a way that is contrary to the GTA.

The object of the GTA is to (among other things):

"Protect the health and safety of people, and to protect the environment by identifying risks posed by or as a result of Gene Technology, and by managing those risks through regulating certain dealings with Genetically Modified Organisms ("GMOs")".

The GTA regulates dealings with organisms and their products that are modified through various forms of technology. The GTA applies not only to genetic modification of plant matter, but also includes the modification of micro-organisms for therapeutic purposes, research in biology with transgenic animals as well as certain research involving human beings.

Application of the GTA

The GTA outlines the ways in which an organisation may deal with GMO’s. An organisation will be deemed to have dealt with a GMO if it:

• conducts experiments with a GMO;
• makes, develops, produces or manufactures a GMO;
• breeds a GMO;
• propagates a GMO;
• uses a GMO in the course of manufacturing a thing that is not a GMO;
• grows, raises or cultures a GMO; or
• imports a GMO.

The GTA covers both dealings with GMO’s and dealings with Genetically Modified Products.

What does the GTA deem to be a GMO?

Under the GTA, Gene Technology includes any technique which modifies genes or genetic material. However, it does not include:

• sexual reproduction;
• homologous recombination; or
• any other technique prescribed under the regulations.

In the context of the GTA, a GMO is defined as:

• an organism that has been modified by Gene Technology;
• an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of Gene Technology; or
• anything declared by the regulations of the GTA to be a GMO.

An "organism" is any biological entity capable of reproduction or capable of transferring genetic material. However, a GMO does not include:

• a human being, who has been modified by Gene Technology only by way of somatic cell gene therapy; or
• an organism declared by the regulations not to be a GMO, or that belongs to a class of organisms declared by the regulations not to be a GMO.

Accordingly, research involving the genetic modification or manipulation of human body parts, tissue, fluid, reproductive material or cells is regulated by the GTA. This is likely to include genetic modification of embryonic stem cells and organisations currently undertaking such research must ensure that they meet the requirements to do so under the Act.

When can an organisation conduct GMO research?

The GTA permits organisations to deal with GMOs only if the dealing is:

• under a licence;
• a Notifiable Low Risk Dealing ("NLRD");
• exempt under the regulations; or
• is included on the GMO Register.

Licence to Deal with a GMO

Under the GTA, an organisation must apply to the GTR for a licence to undertake certain dealings with a GMO. There are essentially 2 forms of dealings capable of licence, namely:

• intentional release of a GMO into an environment; and
• non-intentional release of a GMO into an environment.

Upon receipt of any licence application for a proposed dealing with a GMO, the GTR will prepare a risk management plan and risk assessment. In some instances the GTR may seek advice in the preparation of the risk assessment and risk management plan from the States, the Gene Technology Technical Advisory Committee and other appropriate bodies.

Notifiable Low Risk Dealings ("NLRDs")

In essence, NLRDs include:

• dealings which do not involve the intentional release of a GMO into the environment; or
• any GMO declared by the regulations to be a NLRD.
• The GTA requires the GTR to determine whether a dealing with a particular GMO is a NLRD. When doing so, the GTR must consider a number of factors including:
• whether the GMO is biologically contained so that it is not able to survive or reproduce without human intervention; or
• whether the dealing with the GMO would involve minimal risk to the health and safety of people and to the environment.

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.