January 11th 2003


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Articles from this issue:

COVER STORY: Paid maternity leave: who benefits?

CANBERRA OBSERVED: 2002: when the chickens came home to roost

EVENTS: Claudio Betti to visit Australia

BIOETHICS: Embryo battle was worth the fight

STRAWS IN THE WIND: To America with love, from Osama bin Laden

LETTERS: Real world (letter)

LETTERS: Comparisons (letter)

PROFILE: Dr George Pell: Australia's leading churchman

SOUTH ASIA: India's ethnic conflicts

COMMENT: In the wake of the Cultural Revolution

BOOKS: The Life of Matthew Flinders, by Miriam Estensen

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BIOETHICS:
Embryo battle was worth the fight


by Richard Egan

News Weekly, January 11, 2003
Richard Egan explains why the battle over human embryo experimentation and cloning is so important, and where it will go from here.

The Research Involving Human Embryos Act 2002 will come into effect this year, permitting, under licence from a Commonwealth committee, destructive research on human embryos judged to be "excess" to the requirements of women undergoing IVF.

Research on human embryos is intimately linked to IVF and related reproductive technologies. Louise Brown was, in 1979, the first child born following in vitro fertilisation. Within five short years the Warnock Committee in the United Kingdom had recommended in favour of allowing human embryos to be used for scientific research, including both excess embryos from the IVF clinics and human embryos created specifically for research.

In the same year - 1984, the date of Orwell's literary dystopia - the Waller Committee in Victoria made a similar recommendation, although baulking at specifically creating embryos for research.

B.A. Santamaria, responded to these developments in a booklet titled "Test Tube Babies?" He warned that to stop destructive embryo research, cloning (then still speculative) and other biotechnological horrors it was necessary that

"the entire procedure [IVF] should be stopped in this country regardless of what is done in others. This is because once the first, allegedly compassionate, step has been taken, we will inevitably do what we have done with nuclear weapons and go uncontrollably to the very end of the line. The attempt to draw a line by treating IVF between husband and wife as acceptable runs into the fatal obstacle of what is to be done with fertilised eggs left over."

Mr Santamaria concluded his booklet, "The spirit in which these words have been written is not one of optimism. Whatever the problem, the answer always tends to be the same. 'We cannot turn the clock back.' 'The genie has escaped from the bottle'."

Yet one may be forgiven for believing that as the Gadarene swine rushed to the brink of the precipice it would have been better if someone had shouted: "Stop. You are mad. You are rushing to your own destruction." It probably would have made no difference to the result. The Gadarene swine would not have stopped. They would have drowned, regardless. But the intervenor would have been right; and the Gadarene swine would have been wrong."

The Senate Select Committee on the Human Embryo Experimentation Bill 1985 concluded that "the respect due to the embryo from the process of fertilisation onwards requires its protection from destructive non-therapeutic experimentation".

The Committee also found that "any supposed distinction between so called 'spare' embryos and those created specifically for experimental purposes to be ethically unsound" and recommended that "the concept of guardianship be adopted as the most appropriate model to indicate the respect due to the embryo in this context".

In a dress rehearsal for the 2002 debate on embryonic stem cells, Alan Trounson thundered petulantly in response to the Senate Committee's report:

"We are so very close to comprehending the origins of many tumors, and it is probable that many of the lost pieces of the mosaic required to understand cancer appear to exist in developmental embryology.

"God help those who are to die from cancer if the moralist view prevents those young scientists from finishing the mosaic because we would rather dispose of some human embryos than make them available for this research.

"I hope I have left my country and left medical research by the time the legislation has succumbed to the moralist view, that it is better to let children be born with disease we could have prevented or people suffer the pain of a disease or injury we might have treated, because cells of the preimplantation embryo have been given legal status equal to them."

Although the Commonwealth Parliament never passed the Human Embryo Experimentation Bill 1985, which was a private member's bill introduced by Senator Brian Harradine, legislation reflecting the Committee's position was passed in Victoria, South Australia and Western Australia prohibiting destructive or harmful research on human embryos.

The remaining States and Territories have had no legislation governing reproductive technology and destructive research on human embryos has been permitted.

It was the cloning of Dolly the sheep in Scotland and the isolation of human embryonic stem cells in Wisconsin, both in 1997, that put cloning and human embryo research on the agenda in all developed countries.

While the Australian Health Ethics Committee in December 1998 produced a report opposed to human cloning, the Australian Academy of Sciences came out with a report in favour of so-called "therapeutic cloning".

This was a misleading term invented to describe a hypothetical process in which a human embryo would be cloned using donated (or purchased) ova and the nucleus of a cell from an adult patient.

The cloned embryo would be grown for 5-7 days and the human embryonic stem cells harvested from it, causing its destruction. The stem cells would then be cultured and differentiated to produce cells of the type needed to treat the patient.

This process has been promoted, mostly by investor scientists talking up share prices or chasing lucrative Government grants and by Hollywood actors with a degenerative disease desperate for a cure at any cost, as the best bet for new therapies for Parkinson's disease, spinal injury and diabetes.

Kevin Andrews, MHR for Menzies, chaired a House of Representatives Committee which considered cloning and human embryo research. In August 2001 it proposed a moratorium on cloning, including cloning for stem cell extraction, but split on embryo research, with a majority in favour. Andrews, who was given portfolio responsibility for the issue by the Prime Minister, nonetheless took a proposal to Cabinet seeking a ban on both cloning and destructive embryo research.

Prime Minister Howard, after discussing the issue with scientists, including Alan Trounson, and religious leaders, including Archbishops George Pell and Peter Jensen, and under pressure from State Premiers, especially Bob Carr who threatened to "go it alone", came out in favour of permitting destructive embryo research. He could not, he said, see sufficient moral difference between allowing excess IVF embryos to die and using them for research. He was also persuaded that embryonic stem cell research held the promise of medical breakthroughs.

The outline of uniform national legislation to prohibit human cloning, but to license research on excess IVF embryos, was agreed by the Council of Australian Governments on April 6, 2002.

The legislation was subsequently split by the House of Representatives into two bills. The Prohibition of Human Cloning Bill 2002 passed the House and, later, the Senate unanimously. This was a significant achievement for Australian opponents of cloning, given that the United Kingdom has permitted cloning for research, and the United States Senate, under Democrat majority control, has blocked progress of an anti-cloning bill.

Trounson and many other Australian scientists are on the record rejecting the need for cloning in order to advance human embryonic stem cell therapies. It ought to be difficult for them to persuade the Parliament to go back on this comprehensive, unanimous ban when the legislation is reviewed in 2005.

The other bill, at that stage called the Research Involving Embryos Bill 2002, passed the House of Representatives by 99 votes to 33. The Bill was then referred to the Senate Community Affairs Legislation Committee.

The Committee report made it clear that therapies based on human embryonic stem cells are speculative and, for a variety of reasons, including the problems of immune rejection, tumour formation and genomic instability, are unlikely to succeed clinically.

By contrast, therapies based on adult stem cells have already been clinically successful and significant clinical trials are underway including, in Australia, trials for Parkinson's, spinal injury and heart disease.

Middle course

In Senator Knowles' "Chair's report" the notion of "a third way" between the denial of any moral status to the early embryo and the ascription of the same status as possessed by adult human beings was put forward. This "third way" was in the tradition of the 1984 Warnock Committee which had spoken of "respect" for the human embryo while allowing its use in destructive research.

It has taken nearly 20 years, but in December 2002 Baroness Warnock finally conceded that the use of the word "respect" in this context was "rather foolish". "You cannot", she now admits, "respectfully pour something down the sink, which is the fate of the embryo after it has been used for research".

The Bill was then subjected to a lengthy Senate debate where over 60 amendments were put by a committed team of opponents of human embryo research including Senators Brian Harradine and Shayne Murphy (Ind); John Hogg, Jacinta Collins and Mark Bishop (ALP); Guy Barnett (Lib) and Ron Boswell (NP). Their amendments were designed to hold the supporters of the Bill to the COAG agreement which had called for a "strict regulatory regime". However, the Senate majority, with Health Minister Kay Patterson acting under apparent instructions from the Prime Minister to reject all substantial amendments, voted most of these down.

Defeated amendments included an attempt to preserve the State laws banning embryo research until they were changed by the respective State Parliaments and to preclude COAG lifting the restriction on research using human embryos created after April 5, 2002 without reference back to the Commonwealth Parliament.

The defeat of an amendment prohibiting the use of live human embryos for testing or manufacturing pharmaceuticals and cosmetics demonstrated that the debate had moved well beyond the original justification of stem cell therapies. The principle endorsed by the Senate majority was that living human embryos could be used for any purpose approved by the Licensing Committee. The "strict regulatory regime" apparently equates to "trust the committee".

In a piece of brazen hypocrisy, Senator Kay Patterson, who had, in concluding the second reading debate, expressed serious doubt as to whether opponents of human embryo research who would have the ethical consistency to refuse therapies based on such research, opposed an amendment that would have required the labelling of pharmaceuticals and cosmetics that had been tested on or manufactured using human embryos or human embryonic stem cells.

She also refused to support an amendment to protect employees and students who have a conscientious objection to human embryo research from being victimised or coerced to act contrary to their consciences.

Other rejected amendments included a proposed prohibition on selecting embryos as excess and available for research solely on the basis of their sex. Attempts to ensure full disclosure of all licensed research regardless of "commercial-in-confidence" claims; to protect whistleblowers who reveal to proper authorities ethically contentious research approved by the Licensing Committee but kept secret for "commercial-in-confidence" reasons; to allow public interest challenges to license applications before and, by appeal, after approval were all rejected.

However, 14 amendments were accepted by the Senate. Senator Harradine was successful in getting the word "human" inserted into the title of the Bill so that at least the new statute will be honestly labelled as the Research Involving Human Embryos Act 2002.

Other accepted amendments

  • tightened the definition of "diagnostic investigations" to prevent this exemption being used as a loophole for research without a licence;
  • strengthened the offence of using an embryo that is not an excess ART (assisted reproductive technology) embryo by limiting the permitted use to "a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre" rather than to any use included by the Fertility Society of Australia in its Code of Practice;
  • required six monthly and on demand reports to the Parliament by the NHMRC Licensing Committee; ensured that guidelines for consent and other guidelines be taken into account by the Licensing Committee are to be made under regulations and therefore be disallowable by either House of Parliament;
  • excluded persons with a "direct or indirect pecuniary interest in a body that undertakes uses of excess ART embryos" from being appointed to the Licensing Committee;
  • introduced automatic revocation of any embryo research licences held by a person convicted for an offence under this Act or the Prohibition of Human Cloning Act 2002; and
  • directed the NHMRC Licensing Committee in considering a licence application to have regard not just to "the number of excess ART embryos" but to "restricting the number of excess ART embryos to that likely to be necessary to achieve the goals of the activity or project proposed in the application".


Although various proposed amendments relating to the export or import of human embryos or the products of human embryos were rejected, the debate on these matters did lead to a commitment by the Prime Minister to introduce changes to the Customs Regulations for a one year moratorium on the export of human embryos and a similar one year ban on the import of a human embryo clone or products derived from a human embryo clone.

Democrats

Attempts to prohibit patenting of human embryonic stem cells were defeated with the support of Senator Stott-Despoja, despite her past calls for restrictions on patents involving human life or human tissue.

This was not, she pontificated, the time or place. Nor would she, despite moving a successful amendment to the terms of reference for the review due in 2005 to include "the applicability of establishing a National Stem Cell Bank", support a Greens' amendment to prevent the issuing of licences for destructive embryo research until such a National Stem Cell Bank was in place.

The multinational biotechnology industry should be pleased with the Australian Democrats for helping ensure that private sector profits from patenting and selling human embryonic stem cell lines to pharmaceutical companies is allowed under the new Act.

The final amendment of note was moved by Senator Murphy. It requires the review of the Act to be undertaken by persons appointed by the NHMRC and the Minister for Health with the approval of the States to be tabled in both Houses of Parliament. The bill had only provided for the report to be given to COAG. There was no obligation to make it public.

The role of COAG in this whole affair is disturbing. The Council of Australian Governments has no constitutional status. It is simply a creation of the Prime Minister, Premiers and Chief Ministers. Yet this Act gives COAG the power to alter by written fiat, and without reference to any Parliament, the terms under which a human embryo can be made available for destructive research. The Senate Community Affairs Legislation Committee was denied access to the papers on which COAG made its decisions about the terms of the national uniform legislation and so was unable to get behind the COAG communique of April 2002. In the Senate, Heath Minister Kay Patterson, repeatedly insisted that she could not accept amendments because the bill as it stood had been agreed to by COAG.

It is tyrannical and corrupting for a Parliament - by whatever majority - to authorise the destruction of innocent human lives. The Commonwealth Parliament has done so. This decision is the bitter fruit of the loss of fundamental values in Australian society.

In his 1984 booklet, B.A. Santamaria observed that

"while it would be wrong to say that the majority of the community holds positively to the utilitarian philosophies associated with the names of either Professors Singer or Tooley, the fact remains that in a post-Christian society, in which the Christian ethic has ceased to be a determining influence, the overwhelming public reaction is one of moral agnosticism accompanied by an almost total indifference to the issues at stake."

He predicted that in such a climate the supporters of unfettered science would succeed because "they are effectively in positions of power. They control both the laboratories and the medical research committees. Behind them are the financial resources of governments, and in many cases, the apparently limitless resources of the pharmaceutical companies".

Nonetheless, all those who contributed to the opposition to this bill should be proud to have done so. As well as the achievement of the unanimous passage of the Prohibition of Human Cloning Bill 2002, the public and parliamentary debate on the Research Involving Human Embryos Bill 2002 has ensured that the ethical and scientific issues involved have been thoroughly aired and the inflated claims and the pecuniary interests of noted proponents of embryo research exposed. The tabling of the 2005 review in Parliament will be the occasion for a further effort to curtail this research.

In the meantime, opponents of human embryo research will monitor the research conducted under the licensing regime and seek to draw public attention to the expected failure to produce viable therapies.

Politically the battleground now shifts to the States and Territories were each Parliament must debate corresponding State legislation designed to ensure the comprehensive constitutionality of the new law.

By the next round of State and Federal elections (excluding the 2003 New South Wales election) electors should know where every sitting member of the Commonwealth and State Parliaments stands on the destruction of innocent human life.

It is far from clear what set of cultural, religious, social or political developments will suffice to reverse the trend in Australia of rapidly diminishing respect for human life and civilised values.

Meanwhile, those who do respect human life and maintain civilised values can either opt for the unthinkable alternative of silence in the face of monstrous injustice, cravenly conceding the ground without a fight, or take up arms and fight either to the last man or until the tide turns.

The hard-fought battle by both grass roots activists and members of parliament on this legislation confirms that surrender is not an option.




























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