Editorial : Law and ethics for the bioeconomy and beyond

The convergence of biological, technological and economic realms of life has fostered the development of the bioeconomy as a new feature of contemporary society. As the meaning of life and the human body is redefined in the context of the bioeconomy, new challenges have emerged for ethics and law In the face of these challenges, it is imperative that the currency of regulatory frameworks is maintained through the processes of regular review and update. The National Health and Medical Research Council has recently released the new National Statement on Ethical Conduct in Human Research to provide guidance for health research in Australia. The new National Statement will play an important part in supporting innovation and the development of the knowledge economy.

The attack of the clones: Patent law and stem cell research

This article considers the integral role played by patent law in respect of stem cell research. It highlights concerns about commercialization, access to essential medicines and bioethics. The article maintains that there is a fundamental ambiguity in the Patents Act 1990 (Cth) as to whether stem cell research is patentable subject matter. There is a need to revise the legislation in light of the establishment of the National Stem Cell Centre and the passing of the Research Involving Embryos Act 2002 (Cth). The article raises concerns about the strong patent protection secured by the Wisconsin Alumni Research Foundation and Geron Corporation in respect of stem cell research in the United States. It contends that a number of legal reforms could safeguard access to stem cell lines, and resulting drugs and therapies. Finally, this article explores how ethical concerns are addressed within the framework of the European Biotechnology Directive. It examines the decision of the European Patent Office in relation to the so-called Edinburgh patent, and the inquiry of the European Group on Ethics in Science and New Technologies into The Ethical Aspects of Patenting Involving Human Stem Cells.

Data mining traditional Chinese medicine (TCM) lessons learnt from mining in law and allopathic medicine

Key decisions at the collection, pre-processing, transformation, mining and interpretation phase of any knowledge discovery from database (KDD) process depend heavily on assumptions and theorectical perspectives relating to the type of task to be performed and characteristics of data sourced. In this article, we compare and contrast theoretical perspectives and assumptions taken in data mining exercises in the legal domain with those adopted in data mining in TCM and allopathic medicine. The juxtaposition results in insights for the application of KDD for Traditional Chinese Medicine.

The placebo effect: international patent law and the protection of traditional plant medicine

Une préoccupation essentielle traverse cette thèse: l'indifférence systémique de la Loi internationale sur la propriété intellectuelle a l'égard des savoirs traditionnels autochtones. De manière générale, un écart semble d'ailleurs croissant entre l'importance des accords internationaux sur les questions d'intérêt commercial et ceux de nature sociale. Les savoirs traditionnels autochtones sur les plantes médicinales sont particulièrement désavantagés dans ce système dichotomique puisqu'ils sont non seulement à l'origine d'énormes profits commerciaux mais se trouvent aussi au cœur de multiples croyances propres à ces sociétés. L'Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (ADPIC) de l'Organisation mondiale du commerce (OMC) a cristallisé le souci de la législation internationale à l'égard d'une protection efficace des intérêts commerciaux. Deux années auparavant, la Convention sur la diversité biologique (CDB) était signée, traduisant une préoccupation à l'égard du développement durable, et elle devenait le premier accord international à tenir compte des savoirs traditionnels autochtones. On considère souvent que ces deux accords permettent l'équilibre du développement commercial et durable, requis par l'économie internationale. Après plus ample examen, on a plutôt l'impression que l'idée d'une CDB défendant, avec succès et efficacité, la nécessité du développement durable et des savoirs traditionnels autochtones contre les pressions opposées de l'ADPIC et de l'OMC est, au mieux, simpliste. La thèse explore également la fonction de la Loi sur les brevets dans la création d’industries, notamment pharmaceutique, et la manière dont ces industries influencent la législation nationale et en particulier internationale. De même, elle traite du rôle que jouent les brevets dans l'affaiblissement et la dépossession des peuples autochtones dotés de savoirs traditionnels sur les plantes médicinales, conduisant à une situation ou ces savoirs sont marginalisés ainsi que leurs détenteurs. La thèse aborde les failles institutionnelles du système juridique international qui permet une telle situation et indique l'urgente nécessité d'examiner attentivement les inégalités économiques et sociales au Nord comme au Sud, et non seulement entre eux. Finalement, la thèse suggère que la législation internationale gagnerait à s'inspirer des diverses traditions juridiques présentes à travers le monde et, dans ce cas particulier, peut être les détenteurs des connaissances traditionnelles concernant les plantes médicinales seront mieux servi par le droit des obligations.

Law, poetry and medicine: the literate professionals in autonomous Gaelic Ireland, c.1250 - c.1630

This thesis is about a class of literate professionals that served as hereditary brehons, poets and doctors to the Gaelic aristocracy over a period from c.1250-c.1630. My investigation into these families brings together evidence from Gaelic and English sources to highlight the work these families did for their patrons, their status in society and their subsequent fall in the seventeenth century. Such a broad canvas allows us to observe the vibrancy of Gaelic literary culture as these families adapted to the changing political landscape to absorb new Anglo-Norman patrons and assimilated English and Continental ideas while maintaining their distinctive identity. I want to look beyond the ideology espoused by these families to look at the practical choices members of these families made to maintain their status and relevance in a changing social context. To do this I have chosen to focus on each of the three professions in individual chapters to highlight the continuities and changes within the professions and ultimately by comparing the three groups to gauge the success or failure of these professional families to adapt to the encroachment of the New English and the ultimate collapse of the Gaelic world. This thesis takes a holistic approach to these families by including branches of these families not engaged in the hereditary profession. It seeks to provide a broader picture of Gaelic society below the level of the aristocracy by looking at the geographic distribution of these families, their proximity to centres of power, and to land and sea routes that can indicate their involvement in alternative economic activities.

Termination of a minor’s pregnancy : critical issues for consent and the criminal law

The recent Supreme Court decision of Queensland v B [2008] 2 Qd R 562 has significant implications for the law that governs consent and abortions. The judgment purports to extend the ratio of Secretary, Department of Health and Community Services (NT) v JWB and SMB (1991) 175 CLR 218 (Marion’s Case) and impose a requirement of court approval for terminations of pregnancy for minors who are not Gillick-competent. This article argues against the imposition of this requirement on the ground that such an approach is an unjustifiable extension of the reasoning in Marion’s Case. The decision, which is the first judicial consideration in Queensland of the position of medical terminations, also reveals systemic problems with the criminal law in that State. In concluding that the traditional legal excuse for abortions will not apply to those which are performed medically, Queensland v B provides further support for calls to reform this area of law.

Law autonomy and advance directives

The principle of autonomy underpins legal regulation of advance directives that refuse life-sustaining medical treatment. The primacy of autonomy in this domain is recognised expressly in the case law, through judicial pronouncement, and implicitly in most Australian jurisdictions, through enactment into statute of the right to make an advance directive. This article seeks to justify autonomy as an appropriate principle for regulating advance directives and relies on three arguments: the necessity of autonomy in a liberal democracy; the primacy of autonomy in medical ethics discourse; and the uncontested importance of autonomy in the law on contemporaneous refusal of medical treatment. This article also responds to key criticisms that autonomy is not an appropriate organising principle to underpin legal regulation of advance directives.

Access to medicine and the dangers of patent linkage : lessons from Bayer Corp v. Union of India

In February 2010, the Delhi High Court delivered its decision in Bayer Corp v Union of India in which Bayer had appealed against an August 2009 decision of the same court. Both decisions prevented Bayer from introducing the concept of patent linkage into India’s drug regulatory regime. Bayer appealed to the Indian Supreme Court, the highest court in India, which agreed on 2 March 2010 to hear the appeal. Given that India is regarded as a global pharmaceutical manufacturer of generic medications, how its judiciary and government perceive their international obligations has a significant impact on the global access to medicines regime. In rejecting the application of patent linkage, the case provides an opportunity for India to further acknowledge its international human rights obligations.

Globalisation and Health : Challenges for Health Law and Bioethics

This timely collection explores ethical and legal dilemmas in healthcare arising from globalization. Conflicts between public interests and individual rights, the challenge of regulating professionals and access to health services, and the effects of a global market all feature prominently in contemporary debates in this area. As a result of globalization, issues in health law and bioethics can no longer be understood solely within political boundaries that define traditional notions of individuals and communities. Rather, solutions for emerging problems require a global conception of rights and obligations, including the re-evaluation of ethical frameworks and legal regimes that currently govern exchanges in healthcare. Leading scholars in bioethics, law, medicine and philosophy from various jurisdictions engage these themes in this volume, and demonstrate the need for transnational solutions in a global age of healthcare.

The human embryo as property? Cryopreservation and the challenges for law

The development of the new reproductive technologies has presented significant challenges for policy makers and law reformers. This article focuses on the particular challenges posed by cryopreservation of embryos. These issues are analysed through discussion of relevant Australian statutory provisions and United States case law. The article concludes with a consideration of whether the property model provides an appropriate framework for reproductive material.

Review: "Controversies in Health Law" by In Freckelton and Kerry Peterson

During the past couple of decades health law has been transformed. Within that period we have been confronted with advances in medical science, particularly in genetics, reproductive technology and life-sustaining treatments. Health care has become more expensive, more consumer oriented and more litigious. In addition, the ethical implications of these developments, and the role for law, both as a regulator of health care and in its responses to emerging challenges, have occupied policy-makers, law reformers, health professionals, ethicists and the broader community in Australia and overseas. While many issues have emerged from these developments, there have been few easy solutions...

Guest editorial : the body and the law

This issue of the Journal of Law and Medicine seeks to explore the law's relationship with the human body within a broad context of social, cultural and technological considerations. It does this both in terms of the ways in which the law constitutes the body (for example, by labelling it as property or otherwise), and in terms of the legal rules which regulate rights to bodies and body parts.

23andMe Inc.: Patent law and lifestyle genetics

The venture, 23andMe Inc., raises a host of issues in respect of patent law, policy, and practice in respect of lifestyle genetics and personalised medicine. The company observes: ‘We recognize that the availability of personal genetic information raises important issues at the nexus of ethics, law, and public policy’. 23andMe Inc. has tested the boundaries of patent law, with its patent applications, which cut across information technology, medicine, and biotechnology. The company’s research raises fundamental issues about patentability, especially in light of the litigation in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories Inc. and Association for Molecular Pathology v. United States Patent and Trademark Office and Myriad Genetics Inc. There has been much debate and controversy over 23andMe Inc. filing patent applications – particularly in respect of its granted patent on ‘Polymorphisms associated with Parkinson’s Disease’. The direct-to-consumer marketing of genetic testing by 23andMe Inc. has also raised important questions of bioethics and human rights. It is queried whether the terms of service for 23andMe Inc. provide adequate recognition of the concepts of informed consent and benefit-sharing, especially in light of litigation in this area in the United States. Given the patent thickets surrounding genetic testing, the case study of 23andMe Inc. also highlights questions about patent infringement and patent exceptions. The future reform of patent law, policy, and practice needs to take into account new developments in lifestyle genetics and personalised medicine – as exemplified by 23andMe Inc.