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.