What is the stated intention of the Policy
The health policy chosen for the discussion in this paper is Australia's regulatory framework passed in year 2002 and effective from 16 Jan 2003, governing Stem cells and human cloning research.
This paper attempts to analyse the details of the legislation approved by the Council of Australian Governments (COAG) in Year 2002. The paper would also give the legal framework outlined by the Andrews Committee in the year 2001 which was the basis of the legislation passed by COAG in 2002.
The stated intent of the policy is to “agree that research involving the use of excess assisted reproductive technology (ART) embryos that would otherwise have been destroyed is a difficult area of public policy, involving complex and sensitive ethical and scientific issues.” The policy goes on to mention that “the Council agreed that research be allowed only on existing ART embryos, that would otherwise have been destroyed, under a strict regulatory regime, including requirements for the consent of donors and that the embryos were in existence at 5 April 2002. Donors will be able to specify restrictions, if they wish, on the research uses of such embryos. The Council agreed that research involving the destruction of existing excess ART embryos be permitted under a strict regulatory regime to enable Australia to remain at the forefront of research which may lead to medical breakthroughs in the treatment of disease.” (COAG, 2002)
Definition of Human Cloning
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Often, the public perception is that the Cloning means the replication of individual which is not the case. (Stem cells, 2009) The Standing Committee on Legal and Constitutional Affairs of House of Representatives (referred to as the Andrews Committee after the Committee Chair), in its report on Human Cloning, notes that “it is important to acknowledge that cloning does not necessarily mean the replication of an entire individual” (Science News, 2009).
A working definition of cloning is provided by Australian Academy of sciences which clearly distinguishes between the cloning of whole individual and the cloning of cells and tissues, is as follows (All about Cloning ,2007)
Somatic cell nuclear transfer and human embryonic stem cells isolation are the two cutting edge technologies which are prevalent in the modern cloning methodologies. (Stem Cells basic 2009)
Reason for policy selection
Following are the reasons for selecting this policy -
Human Cloning is an ethically controversial topic with equal number of people favoring and opposing it
Traditional & religious view on the human cloning is to ban it completely, reasoning for which is not scientifically deduced. Nevertheless it has large impact on the Government legislations.
Any legislation or policy on ethically controversial issues is always open to debates and challenges. This paper tries to critically analyze the Human cloning policies for Australia to conclude the relevance and degree of issues handled by these legislations.
List of discussion points used to guide analysis
The analysis would be focused on the following discussion points -
Overview of Australia's health policy on human cloning with a historical background
Critical Analysis of Australian Legislation on Human Cloning
What is its' nature
The Prohibition of Human Cloning Act 2002 bars “human cloning as well as other unacceptable practices associated with reproductive technology in Australia. By laying down prohibitions, the legislation is intended to address concerns (including ethical concerns) about scientific developments in relation to human reproduction and the utilization of human embryos” (COAG, 2002).
What are the issues
Following are the issues for which the legislation was passed (Andrews Committee, 2001):
Opposition to rejected Embryo harvesting.
Embryo created using adult somatic cell transfer technique is produced using asexual method of re-production but this was also strongly opposed because of destruction of Embryo in the transplantation process
Reproductive cloning might well trigger a mad race for it without any genuine reason and can come out as possible threat to human diversity and some people may start selection of genes for cloning
Potential to be used for abuse of women
What reasons are put forward to explain the causes of the issues which give rise to the policy being developed?
Following are the reasons put forward to explain the caused of the issues (Andrews Committee, 2001):
Always on Time
Marked to Standard
People are not comfortable with the idea of harvesting stem cells from an embryo even if it is a result of failed pregnancy as there are possibilities to plan a failed pregnancy
Women from lower class of society or in urgent need of money can be abused to deliver a failed pregnancy resulting in making it an unethical practice of playing with the human lives
Destruction of Embryo in the asexual mode of reproduction
Gene selection by highly influential people can result in a multiple copies of them. People extrapolated the experimentation on Dolly, the sheep, on Human beings and started assuming the scenario when scientists would create the exact replica of a human being
People are not sure about the direction in which the research was progressing and were getting confused with the results produced by the different studies in human cloning and they were feeling that the Government is not taking any step to contain it
Religious leaders were not happy with the Human cloning practice and they wanted an immediate ban on any such practice. There was an implicit agenda of the COAG to quite this protest by introducing a bill which bans Human cloning for a period (for a later revision) while allowing the research for scientific purpose so that Australia remains in the forefront of the Human Cloning technology
Is there a hidden purpose to the policy? (For example, is it a form of social control and if so is that a positive or negative thing in the longer run).
Yes, there seems to a hidden purpose in the policy which is to quite the protest from various quarters on human cloning. Some of these protests were based on beliefs which did not have any logical reason behind it (Religious protests) while some of the protests were coming from confused sections (Fear of creating a clone of a tyrant leader). There were some logical protests as well e.g. fear of abuse of women for harvesting of embryo, planning a failed pregnancy. Hence, this legislation was also intended to be a form of social control.
The positive aspects about it are that the research can continue without much voices in protest, a governance is introduces which would be able to handle an area which was so far un-governed and there was no legal control over it, this also gave an opportunity for everyone to understand human cloning from the Government's perspective (Andrews Committee's 2001 research).
The negative aspect of the social control was the restricted availability of treatment for life-threatening incurable diseases like organ failure, sickle cell anemia, Type 1 diabetes etc. Human Cloning was expected to deliver the treatment of these diseases but the ban by COAG 2002 legislation has turned the clock back. Now, until the researcher's find a safe way of harvesting stem cells, the current treatment of these diseases would remain suspended (COAG, 2002).
What values are indicated by the policy?
The policy indicates following values (Andrews Committee, 2001) -
Opposition of cloning for reproductive purposes
No destruction of Embryo is allowed for therapeutic purposes
Endorsing of adult Stem cell research, encouragement is provided for the same
Value of Human life whether fetal or Embryo stage is respected and appropriate security is provided
Security of Women is ensured from a prospective abuse
What beliefs or ideologies underlie it?
The primary belief is to contain the haphazard destruction of Embryos for the therapeutic or reproductive purposes. The ideology is that nobody must be allowed to take a life to save another life as Embryo is also considered to be a life form.
Another ideology is the safety of all citizens of the country. Government has ensured through this bill that no women can offer for embryo harvesting, willingly or un-willingly, for the purpose of human cloning. This legislation prevents the abuse of women at any level by the people requiring embryo harvesting for any purpose.
Who is directly or indirectly affected by the policy?
Everyone who was directly involved with the research or therapeutic use of human cloning is affected by this legislation. The patients of incurable diseases, who were having hopes of getting a treatment from human cloning technology, are adversely affected by this legislation.
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Indirectly, people across the globe are affected by this legislation as this legislation can act as a basis of similar legislation in other countries. Australia is a developed country and other nations look up to it. This legislation can be a milestone in the global history of the human cloning. All protestors including the religious groups who were against human cloning are also affected by it as their demands are met by this legislation (COAG, 2002).
Who are the target groups?
The target groups are the researchers in the field of human cloning, patients of incurable diseases, hospitals running the treatments using human cloning, protestors against the human cloning including religious protestors and the women (who could have been a subject to abuse).
What are the parameters (biological, social, psychological, cultural)?
The biological parameters are the harvesting of embryos through sexual or asexual method.
The social parameters are the protests by the various groups which are against human cloning.
The psychological parameters are the ethical and moral issues coming up in the mind of people when they come to know about the harvesting of embryos or propaganda created by various groups on cloning of Tyrant kings or politicians.
The cultural issues are cited by the religious groups who feel that none of the religion of the world allows for human cloning and no one should play the role of God by trying to clone the human beings.
What are the population numbers involved?
The exact population numbers are difficult to come up but on a subjective scale, all the patients who could have been treated by human cloning, researchers, hospitals, and protest groups are affected by it.
What is the geographical spread?
The legislation has its jurisdiction across Australia but it indirectly affects the Global population as it has a potential of getting quoted in legislations and bills following this in other countries.
How will the policy be effective?
How is the policy attempting to achieve its goals?
Policy is attempting to achieve its goals by prohibiting the creation of Human Embryo clone by sexual or asexual method without any exceptions, creating any human embryo outside the body of women, except for achieving pregnancy, ART embryos must be allowed to succumb if it is a failed pregnancy, all procedures to create human embryos are banned as well (COAG, 2002).
What methods are being used or proposed?
Any breach of above prohibitions attracts a penalty of 15 years imprisonment (COAG, 2002). Any attempt to undertake cloning for reproductive purposes would result in the withdrawal of license to undertake research in that area as well as it will be subject to criminal penalty. Research using cloning techniques would be subjected to clear legislative parameters, including a complete ban on the deliberate creation of embryos for research purposes.
It was proposed to setup a national licensing body be established to regulate human cloning and research using cloning techniques. The import and export of embryonic stem cells should be permitted with the framework of principles outlined in this report, i.e., it should be permissible to import and export embryonic stem cell lines that are already in existence or have been created using embryos that are surplus to the requirements of assisted reproductive technology programs. (Andrews Committee, 2001)
Are they likely to be successful?
The prohibitions are likely to be successful as it would stop the practice of human cloning and also quite the protestors of human cloning as it meets their demands of banning human cloning.
As the legislation mentions a review after 2 years in the perspective of development of new technology, it is expected to keep pace with the latest developments and hence address the issues developing in future.
What will be the impact on support/ health/aged care agencies?
As mentioned earlier, there will be an impact on the health agencies who take care of the aged people as they are most likely to get affected by nervous diseases like Parkinson's and Alzheimer. Human cloning technology was expected to offer them cure of these incurable diseases (Andrews Committee, 2001).
What is the financial costing of the policy and is it adequate and complete?
There does not seem to be any additional cost of implementing this policy except the development of the policy might have needed some finance.
Are there any additional hidden costs?
There does not seem to be any hidden cost of implementing this policy.
What processes are in place to evaluate the policy's effectiveness?
The policy proposes a 2 year review to keep it in synchronization with the latest technical development in the field of the Human Cloning (COAG, 2002).
Are these politically neutral? Is it possible to be politically neutral in this case, and does it matter?
This process seems to be politically neutral as the new Governments have the opportunity to revise as per the situations in future. It does matter to be politically neutral in this case as the issue involves ethical and moral questions which are fundamental to any human being and cut across any political lines.
Review of Legislations on Human Cloning on whether the policy maintains, or challenges questions of social justice, equity and access
As noted earlier in this essay Andrews's committee was appointed to provide a report on the stem cell research and recommendations on whether this research should continue. The committee propounded a number of points in favor of Stem cell research and human cloning. It recommends that the real benefits of stem cell research should firstly needed to be fully identified before getting any ethical debate on stem cell research .The collected scientific evidence did not happen to suggest any immediate solution to the problems for which the stem cell research was thought to be working on.
They found that the prohibition of stem cell research would not be in favor of the mankind benefit at large, as the research seeks to provide treatment to those chronic diseases which can not be treated using traditional medical practices .Evidence from members of the public, who were suffering from chronic illness, happened to suggest that the stem cell research must be carried out in the hope of finding a cure of their illness
History of Legislations in Australia for Human Cloning. On the last day of July 2000, Australian health ministers met and agreed to develop a policy to regulate human cloning. In Victoria & South Australia, the infertility treatment act 1995 regulates experimentation on Embryos and assisted reproductive technologies. This legislation prevents the human cloning similar to the legislation passed by Western Australia on the subject of human cloning known as Human Reproductive Technology act 1991. In states and territories where the specific regulations regarding Human Cloning do not exist, the subject of Human Cloning is governed by guidelines issues by NHMRC (National Health and Medical research council). On 05 Apr 2002, the council of Australian Governments (COAG) in the leadership of Prime Minister Howard and Premier Carr issued a note to support Stem cell research. The council agreed to provide uniform legislation across states/territories to handle the issue of human cloning. (Politics of Stem cell research therapy 2009)
On social aspects, A Morgan poll conducted during November 2001 found that 70 percent of Australians aged 14 and over approved of extracting stem cells from human embryos to treat disease and injury. Seventy percent also believed that couples with excess embryos after infertility treatment should be able to donate them to research rather than discard them. However, when it came to using a patient's own genetic material to create a cloned embryo to be used as a source of stem cells (i.e. therapeutic cloning), just over half (55 percent) of the respondents approved, with 32 percent disapproving and 13 percent undecided (Morgan Poll, 2001).
Another social & ethical aspect is the non-legislative guidelines issued by NHMRC. In States and Territories where there is no specific legislation regulating cloning and related research, non-legislative guidelines regulate this work. This primarily involves compliance with NHMRC guidelines. The NHMRC has issued two sets of guidelines that guide research in this area. These guidelines are on the Ethical Guidelines on Assisted Reproductive Technology 1996 and the National Statement on Ethical Conduct in Research Involving Humans 1999. The NHMRC requires all institutions or organizations who receive NHMRC funding to establish an Institutional Ethics Committee, and to subject all research involving humans, whether funded by the NHMRC or not, to ethical review by that Ethics Committee using the above National Statement on Ethical Conduct as the standard for that review. The infringement of a provision of any NHMRC guidelines is not an offence, and sanctions for any breach may involve the loss of access to research funds.
Australia does not want to stop any research in this field as a huge potential in terms of cure of many chronic diseases is clearly visible. In spite of debates over ethical and moral issues, the country is not giving into the logic provided by “against cloning” voice. Though a word of caution is what they are giving to the researchers and that it to ensure that the fundamental moral lines are not crossed. Another important point to note here is that the Australia does not want to lose grip over any further researches in this field hence an independent body/structure has been constituted with a responsibility to monitor/allow any further development in this field. The proposed structure is designed to report to the highest executive in the Government so that the right focus is always available.
There are many points that emerged from the discussion. The first one being that the Human cloning and stem cell research is a complex topic which is open to debate .The opinions on the cloning are varied ranging from prohibiting it completely to allowing it freely with some moral ethics. There are differing views on the issue of cloning due to the different cultures .Stem cell research is an area of medical technology which has been identified to be having vast potential to find cure of currently chronic diseases .Gradually, opinion is getting to a consensus of allowing for Stem cell research in a controlled manner where it will be managed by the committee formed by the act of ruling Governments .The committee on human cloning and stem cell research is expected to report the status of the level of research in this fields to the highest office in the Government (President, Prime-minister)
Research on the cloning and stem cells is progressing worldwide and the Governments of the countries need to do a cost benefit analysis on respect for human life to the respective merits of the research in the field of cloning to arrive at the best possible way of advancing in this field .There should not be different regulations for privately and publicly held funds .The legislation of artificial reproductive technologies should be different from the legislation of cloning and stem cell research .Individual researches must be licensed by the central authorizing body .The license of the authorized research centre must be revoked if the research organization is found to be engaged in the cloning for the purpose of reproduction .Regulatory framework must be non-ambiguous, clear and understandable .Clear distinction must exist between the benefits of human cloning for the purpose of curing the medical problems which seem to be non-treatable to cloning for the purpose of creating a copy of the adult human being.
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