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.     

The Lockhart Committee: developing policy through commitment to moral values, community and democratic processes

The Lockhart Committee was appointed by the federal government in 2005 to review the Prohibition of Human Cloning Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth). The issues in the review are ones on which community views differ widely and many people hold strong and diverging opinions. Yet all members of the committee were able to agree on their recommendations when the committee reported to Parliament in December 2005 and since that time, most of its recommendations have been implemented in amendments to federal and State legislation. This article describes the committee's process in considering the issues in the review, in consulting stakeholders and the broader community and in formulating its recommendations.     

Diagnostic testing of genetic disorders: limiting the scope of patent claims through disclosure requirements

The breadth of claims in patents relating to genetic inventions has been controversial for some time. Possible adverse effects of broad claims include inhibiting research and higher costs, restricting patient access to genetic testing. The Australian Law Reform Commission's Report on Genes and Ingenuity--Gene Patenting and Human Health examined this issue, and concluded that the existing disclosure requirements contained in s 40 of the Patents Act 1990 (Cth) provide adequate mechanisms to control the breadth of claims. However, application of these requirements may be problematical in practice due to lack of relevant case law to provide guidance to patent examiners. It has been suggested that this deficit in direct judicial guidance can be obviated by developing appropriate analogies with other chemical systems in decided cases. This article focuses on gene-based diagnostic patents for human diseases, such as those held by Myriad Genetics for testing predisposition towards breast and ovarian cancer using the gene BRCA1. By examining the application of disclosure requirement by courts in genetic and non-genetic chemical inventions, it is possible to provide insight into how this might be applied by courts considering the validity of patent claims for diagnostic testing methods based on mutations in a gene such as BRCA1.     

The human genome, property of all: opportunities under the ALRC inquiry into gene patenting and human health

This article highlights the revolutionary and dramatic implications brought about by the advances in genetics. Among the myriad of legal problems involved, gene patenting is regarded as one of the most controversial. In a critical evaluation of the current inquiry into gene patenting and human health, the author argues that the Australian Law Reform Commission falls short of a thorough recommendation by failing to grant due recognition to the Universal Declaration on the Human Genome and Human Rights. Starting with the fundamental premise that the human genome is the 'heritage of humanity', it is argued that the fruits of genetic research must flow back to humankind, and any law reform process must thereby ensure that the economic and health benefits of genetic research are available to all. Specifically, the Patents Act 1990 (Cth) should be amended to include the 'medical treatment' defence to patent infringement, following the lead of overseas jurisdictions. It should also incorporate an 'experimental use' defence to ensure an unhindered approach to research and development. In doing so, the patent law regime will be truly balancing the interests at stake, which will accommodate more fully Australia's domestic needs and international obligations.     

Grant v Commissioner of Patents and patenting knowledge inventions

This article reviews the Full Federal Court decision in Grant v Commissioner of Patents (2006) 154 FCR 62; 69 IPR 221; [2006] FCAFC 120 denying patentability to a method for structuring a financial transaction so as to protect an individual's assets from a loss of ownership as a result of a legal liability. The article challenges the distinctions drawn by the Full Federal Court and argues that the decision marks a new development in setting a boundary for the Patents Act 1990 (Cth) "manner of manufacture". The article concludese that important questions now arise in assessing the possible application of the Patents Act 1990 (Cth) to promoting some inventions (and innovations) and not others, and whether there are other classes of inventions that also do not require the Patents Act 1990 (Cth) incentives.     

Legal impediments to data linkage

Large numbers of electronic health data collections have been accumulated by both government and non-government agencies and organisations. Such collections primarily assist with the management of health services and the provision of health care programs, with only a minority of these data collections also intended for research purposes. A number of constraints are placed on access to such data for the purposes of research, including data linkage. This article examines those factors arising from the intricacies of Australia's privacy legislation landscape which impede access to such collections. The relevant issues discussed include issues relating to the existence of multiple privacy and health privacy Acts, the recommendations made by the Australian Law Reform Commission in relation to the Privacy Act 1988 (Cth) and the constraints placed on the conduct of data-linkage research which arise from legislation that relates specifically to certain data collections.     

Canada ordered to implement WTO ruling against "stockpiling" of generic drugs

In the last issue, we reported on a mixed World Trade Organization (WTO) ruling regarding Canada's patent laws, based on a complaint by the member states of the European Communities (joined by the United States). In March 2000, a WTO Panel accepted the provision in Canada's Patent Act that creates an "early working exception" to patent rights--in other words, that allows a third party to use a patented invention during the term of patent protection, as long as the use is for obtaining regulatory approval of an equivalent product to be sold once the patent expires. This was an important victory from the perspective of allowing earlier access to generic versions of patented drugs.     

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.     

Legislation and review of medical research with minors in The Netherlands

In The Netherlands medical research with minors is regulated in the Medical Research Involving Human Subjects Act. During the legislation process in the Houses of Parliament in the 1990s the issue of nontherapeutic research with minors and incapacitated subjects was heavily debated. Stringent regulations were formulated for this type of research and the Act became operational in December 1999. In order to implement the Clinical Trial Directive 2001/20/EG, the Act was modified on several issues. However, the Act was not modified on the issue of non-therapeutic research with minors and incapacitated subjects. As a result at present the Dutch law is more restrictive on non-therapeutic research with minors than the EU Directive. Currently, discussion is ongoing to adapt the Dutch law in order to harmonize it with the EU Directive.     

Freedom of information applications as an "evergreening" tactic: Secretary, Department of Health and Ageing v iNOVA Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442

A recent decision of the Federal Court of Australia illustrates how patent-holding pharmaceutical companies are attempting to use Australia's Freedom of Information Act 1982 (Cth) to force Australian safety, quality and efficacy regulators to disclose whether generic competitors are attempting to enter the market. In Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442 a single judge of the Federal Court overturned a decision of the Administrative Appeals Tribunal (AAT) that would have compelled the Australian Therapeutic Goods Administration (TGA) to reveal whether they were in possession of an application to register generic versions of two iNova products: imiquimod and phentermine. In its justification to the AAT for refusing to confirm or deny the existence of any application, the TGA argued that to reveal the existence of such a document would prejudice the proper administration of the National Health Act 1953 (Cth) as it could compromise the listing of a generic on the Pharmaceutical Benefits Scheme. The AAT failed to appreciate the extent to which this revelation to a competitor would have undercut 2004 amendments to the Therapeutic Goods Act 1989 (Cth) that provided penalties for evergreening tactics involving TGA notifications to drug patent-holders and 2006 amendments to the Patents Act 1990 (Cth) which protected the right of generic manufacturers to "springboard". The decision of the Federal Court is one of the first to explore the use of freedom of information legislation by patent-holders as a potential "evergreening" technique to prolong royalties by marginalising generic competition. Because of the significant amounts of money involved in ensuring rapid market entry of low-cost generic products, the issue has considerable public health significance.     

Privacy regulations on biometrics in Australia

This paper aims to provide an analysis of the current regulatory environment, at the federal level, of privacy protection concerning biometrics in Australia. The study only focuses on the federal Privacy Act 1988 (Cth) and the Biometrics Institute Privacy Code. The discussion is based on the legal concerns of the use of biometrics, and an analysis is made concerning the implications of privacy protection sources.     

Protecting Medicare services: trials of a peer review scheme

The Professional Services Review Scheme, established in 1994 under Pt VAA of the Health Insurance Act 1973 (Cth), is a unique attempt to apply peer standards to review of Medicare services. This article examines the evolution of the scheme in the light of extensive litigation.     

Social Security preclusions in personal injury litigation

This editorial scrutinises the impact of preclusion periods for social security entitlements upon personal injury practice. It identifies the differences in calculation in respect of the compensation part of lump sum payments, depending upon whether a plaintiff's case is settled or resolved by litigation. It examines the effect of s 1184K of the Social Security Act 1991 (Cth) and the circumstances in which the discretion to reduce or waive the preclusion period has been exercised in favour of recipients of lump sum payments. It argues that room remains for creative arguments on behalf of plaintiffs, highlighting the potential for the compensatory effect of the lump sum to be undercut if the preclusion provisions are fully applied.     

To lease or not to lease? The leasing of indigenous statutory lands in Australia: lessons from Canada

In Australia, land rights legislation provides statutory schemes for the transfer of land to Indigenous peoples. The first significant land rights legislation was passed by the Australian Commonwealth government in 1976. This was the Aboriginal Land Rights (Northern Territory) Act (ALRA) 1976 (Cth). In 2006, the Australian Commonwealth government passed significant amendments to the ALRA. One of the key amendments introduced the leasing of Aboriginal ‘township lands’ held under that Act. It is these leasing amendments which are a focus of this article. A primary motivation behind the amendments was to decrease poverty in Indigenous communities and to allow for economic development on Aboriginal lands. This article critiques the township leasing scheme under the amended Act. It questions whether the new leasing arrangements are the most appropriate forms of leasing to achieve economic development on Aboriginal lands and to benefit the Aboriginal communities who hold these lands. In 2008, leasing amendments were passed to Queensland's statutory land scheme in the Aboriginal Land Act 1991 (Qld) and these amendments are subject to review in this article. Furthermore, the article examines alternative forms of leasing used for economic development on Indigenous reserve lands in Canada and whether there are lessons that Australia could learn from these tenures and their modes of leasing.     

The introduction of data breach notification legislation in Australia: A comparative view

This article argues that Australia's recently-passed data breach notification legislation, the Privacy Amendment (Notifiable Data Breaches) Act 2017 (Cth), and its coming into force in 2018, makes an internationally important, yet imperfect, contribution to data breach notification law. Against the backdrop of data breach legislation in the United States and European Union, a comparative analysis is undertaken between these jurisdictions and the Australian scheme to elucidate this argument. Firstly, some context to data breach notification provisions is offered, which are designed to address some of the problems data breaches cause for data privacy and information security. There have been various prominent data breaches affecting Australians over the last few years, which have led to discussion of what can be done to deal with their negative effects. The international context of data breach notification legislation will be discussed, with a focus on the United States and European Union jurisdictions, which have already adopted similar laws. The background to the adoption of the Australia legislation will be examined, including the general context of data privacy and security protection in Australia. The reform itself will be then be considered, along with the extent to which this law is fit for purpose and some outstanding concerns about its application. While data breach notification requirements are likely to be a positive step for data security, further reform is probably necessary to ensure strong cybersecurity. However, such reform should be cognisant of the international trends towards the adoption of data security measures including data breach notification, but lack of alignment in standards, which may be burdensome for entities operating in the transnational data economy.     

Data registers in respiratory medicine: a pilot project evaluating compliance with privacy laws and the National Statement on Ethical Conduct in Research Involving Humans

This article reports on data from a small pilot survey evaluating the compliance of voluntary databases in respiratory medicine with privacy laws and the National Health and Medical Research Council's National Statement on Ethical Conduct in Research Involving Humans. The increasing complexity of privacy law, including the recent private sector amendments, creates many challenges for database administrators. The impact of privacy laws upon voluntary or non-statutory databases, and upon doctors reporting patient data to such databases, is far from straightforward. The article suggests way in which the law might be adapted in order to better facilitate the role of voluntary data registers in health research and public health surveillance, while still protecting the privacy of patient information. The article also briefly considers how database administrators might "future-proof" their existing data holdings to ensure compliance with legal and ethical standards.     

Regulating surrogacy--a contravention of human rights?

On the 2nd of October 2000, The Human Rights Act 1998 came into full force, signalling the incorporation of The European Convention on Human Rights into U.K. law. Areas of law believed to be inconsistent with the Convention may now be challenged in both The European Court of Human Rights and domestic courts. This article considers whether existing laws on the regulation of access to infertility services, in particular surrogacy, will be deemed incompatible with the ECHR. Human rights as enshrined within Articles 8 and 12 will be examined in light of recent suggestions that there may arise legal challenges by those who have had access to reproductive services restricted or denied. It will be shown that, although existing and potential future controls may arguably infringe these rights, it is nevertheless unlikely that they will be held to be in contravention of The Human Rights Act 1998.     

Bent into Security: Barrister Contribution to a Skewed Order in Two Terrorism Prosecutions in Australia

This article explores two terrorism prosecutions – R v. Benbrika and Ors and R v. Elomar and Ors – to probe how Australian lawyers approach the integration of national security interests into the heart of public law. A brief background is provided followed by an analysis of how the Security Legislation Amendment (Terrorism) Act 2002 (Cth), as amended, and the National Security Information (Criminal and Civil Proceedings) Act 2004 (Cth) deviate from the legal order to produce a ‘skewed blend’ between national security and criminal justice. We examine three ways in which barristers contribute to bending of process in counter‐terrorism trials: accommodation to the precautionary standard, the resetting of equality of arms expectations, and brokered agreements that depend on the deferential relationships within the court. Consequently, the moral asymmetry of terrorism is the backdrop for the ‘plausible legality’ of ‘just world’ derogations from liberal politics.     

Google liability for misleading or deceptive conduct: Australian perspective

On 6 of February 2013, the Australian High Court handed down an important decision in respect of the Google Inc's (Google) appeal against the decision of the Full Federal Court of Australia, holding that Google a search engine operator was not liable under s 52 of the Trade Practices Act (TPA) 1974 (Cth) for misleading or deceptive conduct (in respect of misleading advertisements published using Google's online ‘AdWords program’). The decision of the High Court is of great significance for jurisprudence on misleading and deceptive conduct with its broad implications for search engine providers such as Google, advertisers and trademark owners.