Stem Cell Essay - Grade: 32/40 PDF

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Bioethics essay- regulation of human embyronic stem cell treatments in Australia. Got 32/40 for this assignment. ...

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Evaluate the regulatory issues that may arise in regulating embryonic stem cell technology Scientific research in Australia continues to rapidly progress as science develops, and as in many other countries, the legal and regulatory schemes in place have tended to struggle to keep up.1 Current and past research contributed from Australian scientists in regards to human stem cells and the potential of stem cell technologies has been invaluable to the medical profession. Without uniformed legislation, issues such as definitions of technologies and inconsistent monitoring are more evident across states and territories. Thus, passing legislation to regulate human embryonic stem cell (HESC) research across the nation will provide protection to scientists and medical professionals and identify clear parameters, scope and accountability.2 Maintaining an effective and progressive regulatory scheme is essential to ensuring law keeps up with both ethical and professional standards. Majority of the ethical contention regarding human embryonic stem cell therapies is concerned with the inevitable destruction of the embryo once it is harvested.3 This has led to various social and religious groups condoning the use of HESC to further biotechnology, thus the law has found difficulties in maintaining a response that adopts the best outcome for all. A sound evaluation of stem cell research needs to take account of the likelihood of achieving its beneficial outcomes.4 For legislators, they must take into 1 Shi-Ning Then, ‘Regulation of Human Stem Cell Research in Australia’ (2009) 5 Stem Cell Reviews and Reports 2 Patrick Foong, Regulating Human Embryonic Stem Cell Research in Australia: Brownsword’s Regulatory Challenges (2016), Curtin Law and Taxation Review, 3, 131-170. 3 Maurice Rickard, ‘Key Ethical Issues in Embryonic Stem Cell Research’ (Current Issues Brief No 5, Parliamentary Library, Parliament of Australia, 2002). 4 Ibid.

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consideration all the potential benefits: deliberating all outcomes and regulate effectively. As there is no single answer to accommodate every view on the subject, the law faces ongoing issues with ensuring to hold the utmost respect in a plurastic approach. A critical need for implementing such regulation highlights that “where there is no regulation to prohibit or regulate an activity, scientists may decide to pursue controversial experiments out of pure interest or sheer curiosity.5 Moreover, a tightly controlled yet progressive adaption to current legislation is essential to maintaining a national regulatory standard. The discovery of the incredible potential for improving biomedicine through the breakthrough of embryonic stem cells brings with it the need to question the value of life itself. The regulation of embryonic stem cell technologies brings into tension fundamental moral principles that we esteem very highly: enjoins the prevention or alleviation of suffering, and the other enjoins us to respect the value of human life.6 The fundamental debate revolves medical advancements. Embryonic stem cells are considered as the gold standard due to their pluripotent nature, through which they have the possibility to redefine medical innovations. The current use of assisted reproductive technologies means that excess human embryos are created knowing that those not used for means of procreation are destined for destruction.7 One key concern with extending legislation to allow for newer lines of technology, including cloning, to be granted licenses pose a probable threat of a ‘slippery slope’. Despite the potential for therapeutic cloning to hold great benefits for the understanding of human biology and capacity to develop therapies for 5 Foong, above n 2. 6 Rickard, above n 3. 7 Andrew Sinclair and Peter Schofield, ‘Human Embryonic Stem Cell Research: An Australian Perspective’ (2007) 128, 2, Cell Stem Cell

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cancer etc, there is a wide concern of an inevitable lead to unethical purposes such as producing live born humans from embryos as a result. 8 Moreover, the Lockhart review recommended that human reproductive cloning should continue to be prohibited on the grounds of both ethics and safety of the community and participants.9 Australian regulation closely follows the international consensus view against reproductive cloning, largely because there is no scientific evidence of a successful cloning of human beings benefiting society. Attempted reproductive cloning would likely produce professional misconduct and malpractice proceedings in any jurisdiction it was attempted; hence the prohibition of human cloning in all countries. Before any form of cloning should be considered to enforce in law, a uniform definition must be made across all states and territories to ensure no discrepancies. In July 2000, Australian Health Ministers agreed the importance of developing a national framework to prevent exploitation of such sensitive issues however little progress has been made.10 Considerably, in 1999 the South Australian Council on Reproductive Technology established a committee on cloning to discuss the loopholes in its legislation, particularly seeking a clear definition of reproductive cloning.11 The Australian Law Reform Commission discussed that the proposed definition suggested by the working party as minimising the difficulty caused by the focus in existing provisions on

8 House of Representatives Standing Committee on Legal and Constitutional Affairs, Parliament of Australia, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (2001) 58. 9 Legislation Review Committee, Parliament of Australia, Legislation Review: Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002 (2005) 10 Dianne Nicol, Donald Chalmers and Brendan Gogarty, ‘Regulating Biomedical Advances: Embryonic Stem Cell Research (2002) 2 Macquarie Law Journal. 11 Ibid.

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genetic identically.12 The attempt of the South Australian Council identified the lacking definitions of cloning and thus highlights the concern for a national definition to eliminate confusion and invalid legislation. In a multi-faith and plurastic society like Australia, the ongoing challenges of regulating such a fast moving field of scientific advancements highlight a need to achieve regulatory legitimacy. The enactment of the Research Involving Human Embryos Act 2002 (Cth) and the Prohibition of Human Cloning Act 2002 (Cth) regulates the use of excess human embryos created through Assisted Reproductive Technology (ART).13 This legislative regime imposes legal impediments to the use of embryos in such research, mainly as a response to religious arguments prioritising a conception of the ‘sanctity of life’. Moreover, the current regulation imposes strict penalties by prohibiting the practice of reproductive and therapeutic cloning, the creation of chimera embryos and commercial trading in gametes or embryos, by making these practices criminal.14 Research proposals involving the use of embryos require institutional human research ethics committee approval and a license from the National Health and Medial Research Council (NHMRC).15Additionally, where research results in the destruction of an embryo, that embryo must have been created prior to 2002. In 2006, both pieces of legislation were amended to allow therapeutic cloning/SCNT for research purposes under certain conditions. To attain regulatory legitimacy, the position that regulators adopt must be considered by all ethical constituencies in society as acceptably 12 Australian Law Reform Commission, Genes and Ingenuity: Gene patenting and human health, ACRC Report 99 (2004). 13 Research Involving Human Embryos Act 2002 (Cth) (RIHE Act); Prohibition of Human Cloning Act 2002 (Cth). 14 RIHE Act s 47. 15 Above n 1. 4

legitimate and ethically appropriate.16 Similarly, the Lockhart Review in 2005 reasoned that “the higher the potential benefits of an activity, the greater the need for ethical objections to be part of a high level and widely accepted in order to prevent that activity”.17 An important note that came from this review highlighted that just because an act may be unethical, it does not necessarily make it criminal. While it is inevitable for divergent opinions on regulating something as controversial as embryonic stem cell technologies, regulators must try to calculate what their community want at an acceptable level of risk but that would not suit everybody.18 One of the main concerns that arise with regulating embryonic stem cell technologies is achieving a framework that is widely accepted and meets the standards of legitimacy. Justice Kirby holds the importance of reasoned debates to settle differenced opinion on such issues, “the very process of consultation and public debate promote a broad community understanding of the issues…and an acceptance of any regulation adopted”.19 Moreover, regulators must keep legislation open for public debate and in constant review in accordance with changing views in order to achieve this legitimacy. Cooperation with legislators, researchers and the public is essential in sustaining an effectual regulatory position in medical research. The established licensing committees and the National Statement on Ethical Conduct in Human Research (NHMRC) set the guidelines for the legislation already in place in Australia. If further amendments to existing legislation were 16 Above n 2. 17 Ibid. 18 Ibid. 19 Michael Kirby, ‘New Frontier’ in Rodger Brownsword and Karen Yeung (eds), Regulating Technologies: Legal Futures, Regulatory Frames and Technological Fixes (Oxford: Hart Publishing, 2008) 375.

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to expand research in the HESC field, there would be a need to establish a national uniform regime and it must display the features of accountability, enforceability, responsiveness, flexibility, practicality and consistency. 20 In order to achieve regulatory effectiveness, intervention must be successful and backed by a legitimate regulatory purpose that is fit for cause.21 When adopting legislation, especially controversial areas such as embryonic stem cell technologies, regulators should act on the basis of consensus because they perform better when they act with the backing of regulates rather than without it.22 Current legislation places heavy restrictions on research with embryonic stem cells, thus assigning inspectors to monitor licensee’s compliance with the law is one strategy to attain regulatory effectiveness. The Research Involving Human Embryos Act 2002 establishes that the licensing committee must issue a license for embryonic stem cell research, through which inspectors are able to monitor licensed premises and the Australian Federal Police have authority to monitor non-licensed premises through a search warrant. Regular intervention by the licensing committee is important to maintaining conformity for those who have been granted licenses. Hence, it is more likely for monitoring committees and regulators to be effective if they set out clear objectives and standards and work together with researchers to maintain these standards. It is imperative for monitoring the licenses’ of researchers, as the scope of stem cell research is highly contentious and thus the law needs to be precise.

20 Above n 10. 21 Above n 2. 22 Stuart Biegel, Beyond our Control? Confronting the Limits of Our Legal System in the Age of Cyberspace (MIT Press, 2003) 359-64.

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Legislators need to provide for future developments and changing in societal thinking and attitudes, allowing for continuous rectification of both guidelines and laws. The innovativeness of technology means that the law must be flexible and able to accommodate to new definitions and technologies. This could be potentially problematic with interpreting the legal position when there is a misunderstanding of the law or the scientific advancements. R v Secretary of State for Health ex parte Quintavattee (ref) is an English case, which succinctly demonstrates the disconnection between the overruling act and the development of new SNCT.23 The issue within this case was the argument that the organisms created by new technology did not fall within the definition of ‘embryo’ in the Act.24 This case highlights an integral need for courts not to fill in gaps of legislation and second-guess the intention of parliament but rather ensure a tightly controlled legislation at the time of creating the law. For regulation to be able to connect and evolve with the ever-changing technology of stem cell research, it is essential to undertake a review of the law regularly and within a reasonable timeframe after the enactment of legislation.25 Mechanisms such as the Australian Law Reform Commission and various reports that examine current legislation are progressive steps that ensure regulation is geared for flexibility and adaptability. A nationally consistent regulatory scheme is an essential feature to the success of regulating human embryonic stem cell research in Australia. The development and advancement of stem cell research in Australia is 23 R v Secretary of State for Health ex parte Quintavalle (on behalf of Pro-Alliance) [2001] 4 ALL ER 1013 [57]. 24 Above n 2. 25 Ibid. 7

progressing rapidly and thus the law calls for new legislation to keep up. All bodies conducting research should be governed by the same rules and researchers should be accountable for professional misconduct and malpractice. More funding to technologies such as cloning and SNCT will be invaluable as science advances and furthers its knowledge to the benefit of society. The complexity of stem cell and genetic technology requires an equally complex regulatory responsive, thus all vehicles must be administered under the same guidelines and enforcement in order to be consistent with legal and ethical norms.

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Bibliography A. Articles/Books/Reports Australian Law Reform Commission, Genes and Ingenuity: Gene patenting and human health, ACRC Report 99 (2004). Biegel, Stuart, Beyond our Control? Confronting the Limits of Our Legal System in the Age of Cyberspace (MIT Press, 2003) 359-64. Foong, Patrick, Regulating Human Embryonic Stem Cell Research in Australia: Brownsword’s Regulatory Challenges (2016), Curtin Law and Taxation Review, 3,

131-170. House of Representatives Standing Committee on Legal and Constitutional Affairs, Parliament of Australia, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (2001) 58. Kirby, Michael, ‘New Frontier’ in Rodger Brownsword and Karen Yeung (eds), Regulating Technologies: Legal Futures, Regulatory Frames and Technological Fixes (Oxford: Hart Publishing, 2008) 375. Legislation Review Committee, Parliament of Australia, Legislation Review: Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002 (2005) Nicol, Dianne, Donald Chalmers and Brendan Gogarty, ‘Regulating Biomedical Advances: Embryonic Stem Cell Research (2002) 2 Macquarie Law Journal Rickard, Maurice, ‘Key Ethical Issues in Embryonic Stem Cell Research’ (Current Issues Brief No 5, Parliamentary Library, Parliament of Australia, 2002).

Sinclair, Andrew and Peter Schofield, ‘Human Embryonic Stem Cell Research: An Australian Perspective’ (2007) 128, 2, Cell Stem Cell Then, Shi-Ning, ‘Regulation of Human Stem Cell Research in Australia’ (2009) 5 Stem Cell Reviews and Reports B. Cases R v Secretary of State for Health ex parte Quintavalle (on behalf of Pro-Alliance) [2001] 4 ALL ER 1013 [57].

C. Legislation Research Involving Human Embryos Act 2002 (Cth) Prohibition of Human Cloning Act 2002 (Cth)

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