Ambiguity of the embryo protection in the Human Rights and Biomedicine Convention: experiences from the Nordic countries

Until 1998 research on in vitro human embryos concentrated on the issues related to assisted reproduction. The situation changed dramatically when the first scientific report on the laboratory culture of human embryonic stem cells was published. This scientific breakthrough with new therapeutic promises put human embryo into a new, more vulnerable position. Combined with creation of embryos via somatic cell nuclear transfer, it inveigles into mass production of embryos, first for scientific purposes, but later perhaps for the healing of people. This article examines the efficacy of the Convention on Human Rights and Biomedicine in protecting embryos in this new era of embryo research. The interpretative latitude of Article 18 of the Convention is demonstrated, and legislation in three Nordic countries with highly variable approach to embryo research regulation is analysed. I examine how this divergence is possible in the light of the Convention text. In the end, potential reasons for variation in regulation in the otherwise similar Nordic countries are discussed, as well as under what conditions harmonisation of regulation on embryo research, a highly value-charged matter, could be possible at the European level.     

Embryonic stem cell research: one small step for science or one giant leap back for mankind?

At the forefront of modern debate over the ethical use of biotechnology is embryonic stem cell research. In this poignant analysis of its legitimacy, the author examines the history of this research in light of the United States' policy favoring the protection of human beings over scientific progress. Stem cells, which can divide in culture to create specialized cells in the human body, possess significant potential for curing disease, particularly when taken from human embryos. However, as evidenced by the research atrocities committed under the Nazi regime, the benefits of human research do not come without a cost to humanity. Recognizing this, the later trial of these scientists produced the Nuremberg Code, a set of natural law principles guiding future research on humans that continues to influence health policy decisions. Drawing on this background, the author first considers the appropriate legal status for a human embryo. Biologically, the characteristics of a human embryo place it between human tissue and a constitutional person. Judicially, the answer is even less clear. The author analyzes case law in the context of abortion and in vitro fertilization, as well as classifications by the common law, state legislation, and the National Bioethics Advisory Commission, to conclude that a human embryo should be subject to the same legal and ethical restrictions as any other "human subject." Accordingly, the author argues that embryonic stem cell research violates the ethical standards and purposes of the Nuremberg Code and should be banned by federal legislation. Such a prohibition will fulfill the societal policy choice of protecting potential life and vulnerable human subjects.     

Stem cell technologies: regulation, patents and problems

Human embryonic stem cell research promises to deliver in the future a whole range of therapeutic treatments, but currently governments in different jurisdictions must try to regulate this burgeoning area. Part of the problem has been, and continues to be, polarised community opinion on the use of human embryonic stem cells for research. This article compares the approaches of the Australian, United Kingdom and United States governments in regulating human embryonic stem cell research. To date, these governments have approached the issue through implementing legislation or policy to control research. Similarly, the three jurisdictions have viewed the patentability of human embryonic stem cell technologies in their own ways with different policies being adopted by the three patent offices. This article examines these different approaches and discusses the inevitable concerns that have been raised due to the lack of a universal approach in relation to the regulation of research; the patenting of stem cell technologies; and the effects patents granted are having on further human embryonic stem cell research.     

The legal concept of personhood in Colombia: are there biological reasons to change it?]

Nowadays, as a consequence of scientific advances in embryology, genetics and assisted reproduction techniques, the scientific community ask for new laws to establish new parameters to use with these recent discoveries. Discoveries that have changed the legal concept of "person". In many countries this concept is absolutely useless when facing new techniques such as cloning, stem cell research and embryo storage. That is why it is necessary to change its definition to guarantee the right to life and give a better protection to human embryos.     

Totipotent, pluripotent or unipotent stem cells: a complex regulatory enigma and fascinating biology

The search for sources of human stem cells has become a controversial topic from an ethical point of view primarily as it has required the destruction of human embryos. The development of alternative techniques that enable the generation of pluripotent stem cells from adult cells has opened new avenues of research but the generation of such cells has again been controversial since it requires the use of human eggs, using a technique called somatic cell nuclear transfer. Since the cells so generated have a very small potential to generate an "embryo" and since the production of the cell lines requires destruction of that "embryo", a further ethical issue arises. This article discusses these issues and suggests a framework that may assist their consideration. Finally, the article reviews some recent developments that have the potential to remove the need for the use of eggs or embryos in the generation of stem cell lines and highlights the danger of developing legislation on only our current knowledge.     

The problems and possibilities in regulating technological frontiers: the politics of the new anxiety?

The revolution in science, biotechnology and medicine of the past 30 years demands a revisitation of old institutional forms and responses, including those of law itself. Scientific citizenship requires that law develop a moral vision and vocabulary so that we shape the moral dimensions of the emergent bioeconomy. Chief among those in the field of biotechnology are technologies of human reproductive cloning, therapeutic cloning and stem cell research using human embryos. Where there are deep pluralist divisions is in relation to therapeutic cloning and embryonic stem cell research. Regulatory flexibility may be opportune in delimiting the extent to which government need stray into this realm of "moral politics". As Brownsword has written, an important developmental vector is what has become known in administrative and public law literature as the concept of "smart regulation". This concept is examined and an attempt to apply it to these fields is made. The enlarged nature of human action -- enlarged in magnitude, reach and novelty -- raises moral issues beyond interpersonal ethics and requires reflection; responsibility is centre stage and calls for lengthened foresight -- what has been called a "scientific futurology". This is also examined.     

Lengthening the stem: allowing federally funded researchers to derive human pluripotent stem cells from embryos

Recent developments in fetal tissue research and stem cell research have led to dramatic breakthroughs in the search for cures for Parkinson's disease, Alzheimer's disease, diabetes, and a host of neurological disorders. Because this research involves fetal tissue and stem cells from human embryos, many complicated ethical and legal implications surround it. This Note explores the history of fetal tissue research and stem cell research, examines the surrounding ethical and legal issues, looks at the current state of federal law, and concludes that Congress should allow federally funded researchers to derive stem cells from discarded human embryos obtained from in vitro fertilization clinics.     

The regulation of science and the Charter of Rights: would a ban on non-reproductive human cloning unjustifiably violate freedom of expression?

Non-Reproductive Human Cloning (NRHC) allows researchers to develop and clone cells, including non-reproductive cells, and to research the etiology and transmission of disease. The ability to clone specific stem cells may also allow researchers to clone cells with genetic defects and analyze those cells with more precisions. Despite those potential benefits, Parliament has banned such cloning due to a myriad of social and ethical concerns. In May 2002, the Canadian Government introduced Bill C-13 on assisted human reproductive technologies. Bill C-13 deals with both the scientific and the clinical use of human reproductive materials, and it prohibits a number of other activities, including NRHC. Although the Supreme Court of Canada has never ruled on whether scientific experiments area form of expression, academic support exists for this notion. The authors go through the legal analysis that would be required to find that scientific experiments are expression, focusing in part on whether NRHC could be considered violent and thus fall outside the protection of section 2(b). The latter question is complicated by the ongoing policy debate over whether an "embryonic cell" is property of human life. The authors then consider whether a ban on NRHC could be justified under section 1 of the Charter. They conclude that both the breadth of the legislative purpose and the proportionality of the measure are problematic. Proportionality is a specific concern because the ban could be viewed as an outright denial of scientific freedom of expression. Although consistent with current jurisprudence on freedom of expression, this paper runs against the flow of government policy in the areas of regulation and prohibition of non-reproductive human cloning. As there has been no Charter litigation to date on whether scientific research is a form of expression, the authors introduce a new way of looking at the legality of the regulation of new reproductive technologies.     

The Morality of Killing Human Embryos

The morality of embryonic stem cell research (ESCR) depends on the moral status of human embryos. I defend the interest view against some of Don Marquis's objections, and show that on his own Valuable Futures account, ESCR is morally permissible.     

Stem cell frontiers: science, ethics and regulation

The isolation of human stem cells and the cloning of "Dolly" in the late 1990s, based on primate and other animal studies in the previous 20 years, created an explosion of interest that continues with daily reports in much of the world's press. The science has progressed steadily but not always smoothly, with promising discoveries in the potency and flexibility of cells derived from embryonic, umbilical cord and adult tissues. The promise of a revolutionary new era in health and medical sciences and systems requires careful scientific method, ethical debate and supportive legal and regulatory frameworks to achieve success. The frontiers of the science are focusing on the regulation of cell lineage choice and the development of designer stem cells for therapeutic cloning; the ethical debate focuses on the special status of the human embryo and the pathways to applications; while legal and regulatory frameworks differ around the world. There is some risk that the promises are overtaking the reality of progress, with the rush for results and premature offering of dubious remedies compromising scientific method and credibility. Stem cells should not be the snake oil of our times, nor should short cuts and short sell promises, fuelled by illusions of fame and fortune, risk the trust of the public in science and medicine.     

Development of stem cells from umbilical cord blood and blood banking: "non-controversial" and "free of political and ethical debate"?

Opponents of human embryo research have understandably welcomed pluripotent stem cells being derived from body cells including cells from umbilical cords after childbirth. The cord would otherwise be discarded and embryos are not destroyed. However, there are other ethical, legal and political issues in cord blood collection, whether for the child's future use, or a public blood bank. Information and consent procedures may be misleading. Some parents have false hopes about potential outcomes. The right of access to stored blood and other benefits is sometimes uncertain for children and their families. Private stem cell repositories may compete with public ones. People may want to impose conditions on donation. Quality control may be an issue.     

Which bank? A guardian model for regulation of embryonic stem cell research in Australia

In late 2005 the Legislation Review: Prohibition of Human Cloning Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth) recommended the establishment of an Australian stem cell bank. This article aims to address a lack of discussion of issues surrounding stem cell banking by suggesting possible answers to the questions of whether Australia should establish a stem cell bank and what its underlying philosophy and functions should be. Answers are developed through an analysis of regulatory, scientific and intellectual property issues relating to embryonic stem cell research in the United Kingdom, United States and Australia. This includes a detailed analysis of the United Kingdom Stem Cell Bank. It is argued that a "guardian" model stem cell bank should be established in Australia. This bank would aim to promote the maximum public benefit from human embryonic stem cell research by providing careful regulatory oversight and addressing ethical issues, while also facilitating research by addressing practical scientific concerns and intellectual property issues.     

Embryonic discourse: abortion, stem cells and cloning

This Article interprets the debate about abortion and the debate about embryonic research and therapeutic cloning as aspects of a larger history of ideas. The Article suggests that embryos increasingly stand for different truths in discourse about abortion on the one-hand and about embryonic stem cell research and therapeutic cloning on the other. More specifically, the Article suggests that the contemporary debate about the meaning of the embryo in the context both of abortion and of embryonic research bespeaks a widespread transformation in Western, and especially American, society during the last three or four decades. At base, that transformation involves displacement of an understanding of personhood, particularly in domestic settings that depended on the submersion of individualism with an understanding of personhood that values autonomous individuality and that envisions community as the consequence of individuals' distinct choices rather than as a pre-existing, hierarchically structured whole.     

人类胚胎的法律地位及胚胎立法的制度构建

随着人工生殖技术的发展,体外受精越来越多,而这与传统的体内受精生殖方式有非常大的差别。同时,胚胎干细胞生物技术的发展也为多种不治之症带来了福音。这就涉及到了一个根本性的问题,即体外胚胎的法律地位究竟如何?这一问题与胚胎归属、继承权、侵权损害赔偿请求权以及能否被应用于科学研究息息相关,不明确胚胎的法律地位,这些问题都不能得到很好的解答。关于胚胎的法律地位,在理论上主要存在三种学说,即主体说、客体说和中间说。通过分析国外立法及比较各种学说,以胚胎为中间体的基础上,可以就我国未来关于胚胎立法的制度构建提出具体建议。     

Legal protection of the genetic heritage in Brazil (comments on the new "Biosafety Law" of March 24, 2005)]

The purpose of the current article is to outline and comment the most important aspects of the regulation of Brazil's criminal legislation about the protection of the human genome, which establishes crimes related to genetic manipulation and to the dissemination of transgenics in the environment. It also refers to the problems related to the application of the old legal text (Law 8.974/1995), which punished conducts that stayed without the enough development. These gaps complicated so much the application of those rules that the Brazilian Parliament has recently proposed the complete modification of the present legislation by a new Biosecurity Law (Law 11.105/2005). This law for the first time authorizes research with human embrionyc stem cells in Brazil, trying thus to solve in this way the problem of cryoconserved human embryos produced by in vitro fertilization programmes. The new law is analyzed here from a legal and ethical view point.     

Canada's Assisted Human Reproductive Act: is it scientific censorship, or a reasoned approach to the regulation of rapidly emerging reproductive technologies?

After more than a decade of study, discussion and debate, the Canadian House of Commons and Senate have approved the Assisted Human Reproduction Act. Building on the earlier Bill C-47, which died on the order paper in 1997, the Act bans human cloning for reproductive or therapeutic purposes, payment for surrogacy arrangements, and trading in human reproductive materials or their use without informed consent. In addition, the Act significantly restricts research using human reproductive materials. This article compares the Act to legislative regimes in other nations with advanced human reproductive science. It concludes that while the Act has many laudable goals, it is flawed in that it tries to cover too much legislative ground. As a result it unreasonable impairs the ability of Canadian scientists to compete in areas such as stem cell research, and area that is expected to yield significant new approaches to treating human disease.     

神经干细胞增殖、迁移及分化调控机制的研究

神经干细胞能够不断增殖、迁移,并具有分化成神经元、星型胶质细胞和少突胶质细胞的能力,神经干细胞的这种特性为研究中枢神经系统退行性疾病及损伤后功能恢复奠定了基础,也为法医病理学死后时间和尸体损伤推断的研究提供了新的机遇。本文对神经干细胞的分布、生物学特性、鉴定、增殖、分化与迁移的影响因素,及其在治疗中枢神经系统疾病和法医病理学中的应用前景作一综述。     

Regulating germ-line gene therapy to avoid sliding down the slippery slope

Many arguments can be made for or against various regulatory approaches towards germ-line gene therapy and its associated research. A popular conclusion is that it ought to be prohibited, and this is commonly defended by use of a slippery slope argument. This paper will begin by outlining the regulatory approaches adopted towards germ-line gene therapy in EU countries, demonstrating the popularity of the restrictive approach. The slippery slope argument will then be examined. A number of variants of the slippery slope argument will be distinguished, highlighting the conceptually different claims made by each. Finally, examples of slippery slope arguments often invoked to support the prohibition of germ-line gene therapy will be examined with regard to the conditions that each must satisfy to form a theoretically sound argument. I will argue that these conditions are rarely given sufficient consideration. For the purposes of this paper, "germ-line gene therapy" is defined as the deliberate genetic modification of germ cells (sperm or oocytes), their precursors, or the cells of early embryos where the germ-line has yet to be segregated.     

Embryonal genetic diagnosis and reproductive freedom in assisted procreation]

This article analyses the repercussions that the Preimplantational Genetic Diagnosis (PGD) has in the bioethical as well as legal fields in relation with the so-called "reproductive freedom" of the couple. Besides analysing the legal situation of this technique in Spain as well as other surrounding States, the article studies the problems associated with some scenarios of PGD, such as the use in the selection of sex, for therapeutic purposes for third parties, in relation with diseases of a possible late onset, multifactorial or of a variable phenotype expression and for the selection of embryos affected by a disease or disability. All are based on real clinical cases.     

Regulating developments in embryonic stem cell research in Africa: a third person's perspective

Among the many advances in modern biotechnology, embryonic stem (ES) cell research has raised perhaps the most intense debate over the ethical, legal and policy issues involved. This debate has centred inter alia on the lives and well-being of the donors or participants in clinical trials, the presumed lives of embryos, the possibility of reproductive cloning, and government funding, among others. These ethical, legal and policy issues tend to overlap and cut across all strata of society, with opponents of the research calling for prohibition and proponents calling for promotion. One important question is whether African countries should regulate to limit or promote developments in ES cell research. This article argues that, in view of the dynamism of modern biotechnology, African countries should regulate in such a way as to maximise the benefits while minimising the disadvantages associated with the research.