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Tuesday, 3 December 2002
Page: 7046


Senator HARRADINE (8:03 PM) —I move amendment (3) on sheet 2751:

(3) Page 11 (after line 5), at the end of Division 2, add:

12B Offence—use of human embryos or human embryonic stem cells in or in testing any pharmaceutical or cosmetic product

A person commits an offence if the person intentionally uses:

(a) a human embryo (including an excess ART embryo); or

(b) human embryonic stem cells;

in, or in the testing, creation or manufacture of, any pharmaceutical or cosmetic product.

Maximum penalty: Imprisonment for 5 years.

The amendment has been circulated, or I hope it has, with further details. If it has not been circulated, I can add—


The TEMPORARY CHAIRMAN — Senator Harradine, my understanding is that you are seeking leave to move amendments (3), (6) and (12) on sheet 2751 together. Would you like to seek leave now?


Senator HARRADINE —I will have another look at what amendment (6) is. I will just move amendment (3). This is a question of pharmaceutical testing on embryos. This amendment will prohibit the use of human embryos or human embryonic stem cells in the testing, creation or manufacture of pharmaceuticals or cosmetics. It is not enough to prohibit the use of human embryos and these activities; it is also important to prohibit the use of embryonic stem cells in this work. A prohibition restricted to human embryos would encourage the destruction of human embryos for their stem cells so that these stem cells could be used for much the same work. I believe the public have been denied information about this matter. Very rarely, if at all, has the question arisen: what will happen to those human embryos? What will happen to those embryonic stem cells? Those who are in favour of this legislation—I am referring not necessarily to people here but to people outside this place—and the scientists concerned have not raised this question. One of the major areas will be the use of embryos, and embryonic stem cells in particular, for the testing of drugs. I believe the public would be appalled if they knew that.

The broader range of destructive human embryo research received less attention than embryonic stem cell research, but this broader use of human embryos includes for examining the effectiveness of new culture media used in assisted reproductive technology, ART, practice; for assisting in understanding embryonic development and fertilisation; for training clinicians in microsurgical ART techniques; for transportation, observation and storage of embryos; for micromanipulation, lasering, cutting and dissecting; for studies in genetic make-up and expression; for quality assurance testing to ensure that pre-implantation diagnostic tests give accurate results; and for drug testing, including toxicology studies on human embryos, as well as for the destructive extraction of embryonic stem cells. Research involving pharmaceuticals and cosmetics is the most likely use of the human embryos and human embryonic stem cells, due to the potential financial returns.

An article in the Australian of 1 April this year reported that Dr Peter Mountford, Chief Executive of Stem Cell Sciences:

... has never produced a human embryo, but holds a patent on technology he believes will achieve this result by the end of 2002. He plans to commercialise the process within two years by supplying disease-carrying embryonic stem cells to pharmaceutical companies for drug screening.

The Centre for Stem Cells and Tissue Repair, which received $46.5 million from the Commonwealth government early this year, states in its application:

A number of companies throughout the world have identified that ES cells in their differentiated or undifferentiated state can be used to develop screening assays to identify new chemical agents for their therapeutic capability or to screen new or existing agents for toxicity in their profile.

Toxicology testing on animals is a costly but essential step in the development of new healthcare products and cosmetics. There is a global trend to move away from the use of live animals for these testing programs, however, there are not yet effective alternative tests developed and approved for use by the relevant regulatory authorities.

Later, that same organisation that the government is providing $46.5 million to, said:

Additionally a number of the world's largest pharmaceutical companies have in-house screening using certain types of cells to discover new drug candidates. This will provide the Centre with the opportunity to generate short-term revenue through the licensing of specific cell lines, and longer-term revenues through participation in Australian based drug discovery programs.

For drug development companies, access to pure populations of differentiated adult stem cells and/or embryonic stem cells of different genetic backgrounds in quantity is keenly sought but currently unavailable.

This legislation will make it available.

The Minister for Industry, Tourism and Resources happens to agree that there is a potential in this area. In correspondence with me, he agreed:

Human ES cell lines for drug screening ... could be a major advantage, and is well appreciated by many pharmaceutical and biotechnology companies worldwide.

Minister Macfarlane then went on to say:

... in vitro drug candidate screening—

and the testing of—

new drug candidates for toxicity and deficiency.

The industry minister also said:

Biotech company BresaGen is interested in distributing these embryonic stem cells to potential new drug developers.

We all thought it was about cures, didn't we?—about the use of embryonic stem cells to apply to sick people.

Senator Patterson has suggested in discussion that it is inappropriate to list unacceptable uses of embryos in legislation, because that might suggest that all other uses are acceptable. But there is nothing in my amendment that would give that impression, and my clarifying comments today make it more than clear that that is not the intention of this amendment. The minister has also suggested that we might also wish to consider restrictions on food allergy testing, air toxin testing and industrial chemical testing. I am more than happy to add these to my amendment.

It is appropriate that we as senators set some limits on the uses of human embryos, not hand over that responsibility to a committee of the National Health and Medical Research Council. We are accountable to the people of Australia; the NHMRC is not. I have heard claims that the NHMRC Licensing Committee will be subject to public accountability and will act in accordance with so-called strict criteria. But, clearly, in this area there is limited accountability. Firstly, the criteria are not strict and the NHMRC is, apparently, in advice to the minister, objecting to the Senate having the temerity to consider making it just a little more accountable with these modest safeguards. Secondly, if there are any complaints about a decision made by the committee the minister will say that the decision was made by an independent body, that it was out of her hands and that the licensing committee is appointed, not elected. Both of them will probably point to the COAG communique as justification anyhow. COAG is not accountable to the people. We cannot see the papers they used to form their decisions, although we have requested those papers. The process is a closed and secretive one. There is no real public accountability. In a climate where we are moving away from the testing of drugs and cosmetics on live animals because of ethical concerns about this practice, it would be disturbing indeed if today we decided to substitute live human embryos as the preferred laboratory animal for drug and cosmetic testing.