Publications

This is a searchable catalogue of the College's most recent books and working papers. Other papers and publications can be found on SSRN and the ANU Researchers database.

Emmanuel Levinas and the Philosophy of Negligence

Author(s): Desmond Manderson

Over the past hundred years, the law of negligence has transformed itself, and in the process transformed our sense of the obligations we all owe to everybody around us – local governments for the services they provide, banks and professionals for the advice they give, drivers on the road, doctors in the surgery, homeowners for their guests or visitors, and even for the trespassers who might pay them a call. Yet what is now compendiously described as ‘the duty of care’ is in some ways an unusual obligation. It is not the outcome of an agreement founded on self-interest, like a contract. It is not a duty owed to the community as a whole and acted on by the State, like criminal law. It describes a personal responsibility we owe to others which has been placed upon us without our consent. It is a kind of debt that each of us owes to others although we never consciously accrued it. Thus it raises in a distinctly personal way one of the oldest questions of law itself: ‘Am I my brother’s keeper?’ What does it mean to be responsible? This is not a question that is easier to answer for us than for Cain. In this article I argue that the idea of responsibility articulated in the law of negligence comes from what might be termed our literal response-ability: it implies a duty to respond to others stemming not from our abstract sameness to others, but rather from our particular difference from them. Responsibility is not a quid pro quo — it is asymmetrical, a duty to listen to the breath of others just in so far as their interests diverge from our own. The duty of care emerges not because we have a will (which the law of contract respects) or a body (which the criminal law protects) but because we have a soul.

Read on SSRN

Centre: CLAH

Research theme: Legal Theory

Tendering for Low Cost Generics in Australia

Author(s):

An Australian federal government committee recently proposed, as a cost-saving measure, the introduction of sealed-bid competitive tendering to exclusively supply the Pharmaceutical Benefits Scheme (PBS) with specific generic medicines. A similar plan involved an open tender to supply generic products below a government set price, also linked with a reduced patient co-payment as an incentive. These proposals represented an opportunity to encourage the price of generic pharmaceuticals to move closer to the marginal cost of production - a process that could be subsequently applied to innovative (or brand-name) patented medicines in a therapeutic class with many competitors. This article examines these tendering proposals, particularly in relation to the potential for increased involvement of generic pharmaceutical manufacturers in the Australian market. Centralised purchasing through tendering for specific generic products has many potential advantages for the PBS;

It would: • allow the PBS system to use cost-effectiveness evaluation linked with their power as largely the sole buyer of medicines in Australia to leverage lower prices; • make prices paid to manufacturers (and other suppliers) more transparent; • give manufacturers (and other suppliers) enhanced certainty over demand than current fluctuating arrangements with wholesalers; • create a negotiating lever to facilitate entry of new generic manufacturers into a more competitive market; • reduce the likelihood of “actual” and “artificial” (“speculative”) supply shortages and facilitate longer and more efficient production runs; • reduce price fluctuations; and • open the door to tendering for innovative products where numerous competitors exist in a therapeutic class. A key benefit of the tendering mechanism is that it will provide a good means for the government and its cost-effectiveness evaluators to gain an understanding of the marginal cost of production for specific PBS-listed medicines. This would be especially true if PBS tenders were in the form of first-price sealed-bid auctions, in which bidders provide a secret bid.

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Jury Reform is Coming: Making the Most of Trial Practice Changes

Author(s): Molly Townes O'Brien

A nationwide movement to reform jury trial practice is underway. At the core of these reforms is an effort to make the courtroom more like a classroom. The current wave of jury reform is designed to take advantage of learning theory that shows that "active learners" remember and comprehend new information better than passive learners. Reforms in jury trial practice now being proposed across the country will allow jurors to take a more active role in the trial, to become "active learners" by allowing them to take notes, ask questions, discuss the evidence with each other, keep notebooks with exhibits and jury instructions, and more. The current wave of jury reform also gives attorneys more opportunities to address the jury and more opportunities to explain the merits of their case. The goal of the reforms is to improve jury comprehension and motivate the jurors to stay awake and attentive.

In general, reforms that treat the courtroom more like a classroom favor the lawyers who are the better teachers. Most trial lawyers already consider themselves to be good teachers. The "active learning" jury should motivate trial lawyers to pick up the chalk and plan to teach even more. Although students/jurors feel more empowered in an active learning environment, it is the person who has something to teach who is most empowered. The teacher is empowered because he or she has an audience that is attentive and better equipped with the tools to learn. The teacher/lawyer will see the reforms as new opportunities to reach into the jurors' minds. The skilled teacher/lawyer will guide note taking, provide excellent written materials for the juror notebooks, and use juror questions to gain insight about how the jurors' view the evidence. In other words, reforms designed to improve juror comprehension will, in the hands of a skilled teacher, give the trial lawyer more and better opportunities to teach and persuade the jury of the justice of their cause.

This short article will give you an overview of recent jury reform initiatives and provide some preliminary thoughts about how trial lawyers can make the most of the coming jury trial practice reforms.

Read on SSRN

Centre: CIPL, PEARL

Research theme: Criminal Law, Human Rights Law and Policy, Law and Social Justice, Legal Education

The Influence of Chinese Immigration on Citizenship

Author(s): Kim Rubenstein

This article is from a paper given at a conference in 2000 which sought to do two things. First it draws out some of the legal issues central to citizenship and displays how they relate to the other disciplines in the development of citizenship in Australia. It argues there has not been a clear legal framework within which to develop an understanding of citizenship in Australia. Secondly, it argues that Chinese immigration to Australia in the second half of the 19th century was central to the evolution of citizenship in this country. Moreover, this factor has influenced the development of a legal framework that is confused, ambiguous, and contradictory about citizenship.

Read on SSRN

Centre: CIPL, CLAH

Research theme: Administrative Law, Constitutional Law and Theory, Human Rights Law and Policy, Law and Gender, Legal History and Ethnology, Migration and Movement of Peoples

Flexner’s Ethical Oversight Reprised? Contemporary Medical Education and the Health Impacts of Corporate Globalization

Author(s):

Abraham Flexner’s famous reports of 1910 and 1912 “Medical Education in the United States and Canada” and “Medical Education in Europe,” were written to assist development of a positive response in university curricula to a revolution in understanding about the scientific foundations of clinical medicine. Flexner pointed out many deficiencies with medical education that retain contemporary resonance. Generally underemphasized in Flexner’s reports, however, were recommendations promoting a firm understanding of and commitment to medical ethics as a basis of medical professionalism. Indeed, Flexner’s praise for the scholastic basic of German medical education became somewhat ironic when the ethical inadequacies of prominent Nazi doctors were revealed at the Nuremberg Trials. This article suggests that contemporary medical educators, like Flexner, may be at risk of inadequately addressing a major challenge to evolving medical professionalism. Whilst medical ethics and health law are now increasingly being emphasized in medical curricula, the same cannot be said of the international human right to health and, in particular, its conflict with lobbying principles arising from the structures of corporate globalization. Today it is this normative tension that must urgently become the subject of major recommendations for reshaping the teaching of medical professionalism. We recommend that contemporary curricula modify instruction in medical ethics and health law to express how such norms are likely to be influenced by, or conflict with, corporate lobbying strategies. Students could learn, for example, the means for distinguishing principles and rules legitimated by the rule of law, from the bargaining devices or constructive ambiguities of corporate globalization. Examples of the latter include “transparency” (in reality, often selective protection of corporate commercial-in-confidence agreements), “recognition of pharmaceutical innovation,” (monopoly protection of brand-name products against less expensive but equally efficacious generic drugs) “liberalization of trade in hospital services” (removal of all regulatory barriers to private ownership) “dismantling of discriminatory price controls” (undermining government drug pricing systems that seek to reference new products against overall social enefit). Such corporate principles are likely to increasingly, discreetly propel professional and social regulation in directions favorable to corporate interests and away from protection of public goods.

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Research theme:

Fiduciary Disclosure of Medical Mistakes: The Duty to Promptly Notify Patients of Adverse Health Care Events

Author(s):

Fiduciary obligations are imposed by the common law to ensure that a person occupying a societal role with a high potential for the manipulation of vulnerable persons exercises utmost good faith. Australian law has recognised that the doctor-patient relationship, while not wholly fiduciary, has fiduciary aspects. Amongst such duties are those prohibiting sexual or financial abuse of patients or disclosure without express authority of confidential information. One important consequence of attaching such fiduciary duties to the doctor-patient relationship is that the onus of proof falls not upon the vulnerable party (the patient), but upon the doctor (to disprove the allegation). Another is that consent cannot be pleaded as an absolute defence. In this article the authors advocate that the law should now accept that the fiduciary obligations of the doctor-patient relationship extend to creating a legal duty that any adverse health care event be promptly reported to the patient involved. The reasons for creating such a presumption, as well as its elements and exceptions, are explained.

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Centre:

Research theme:

The Messiha and Schiavo Cases: Third-Party Ethical and Legal Interventions in Futile Care Disputes

Author(s):

In the United Kingdom, termination of artificial feeding and hydration for patients in a persistent vegetative state generally requires the prior sanction of a High Court judge.UK clinicians also routinely seek judicial resolution of protracted disputes with relatives about ceasing 'futile' active treatment on incompetent intensive care patients lacking a formal advance directive. The same has generally been true in the United States.

Until recently, however, Australian intensivists appear to have lacked either the training or the support to initiate or participate in these types of cases, and the discussion about what Australian courts would do has been largely confined to legal academia. In this article, we examine the recent case of Messiha vs. South East Health (the Messiha case), and the various judicial and political interventions in what has become known as the Schiavo case in the US, for their practical lessons about the role of ethical, legal and legislative interventions in physician approaches to resolving disputes about the technical 'futility' of treatment.

Relatives may increasingly demand that an incompetent patient’s treatment be continued indefinitely, despite clinical advice that it is technically 'futile' (offering no reasonable prospect of return to a meaningful quality of life). Third-party interventions may become a more frequent part of attempts to resolve such disputes where there is no formal advance directive.

In the Messiha case, the Supreme Court of New South Wales upheld clinical judgement regarding the patient’s best interests as most important.

In the Schiavo case in the United States, clinicians’ decisions on futility of treatment had received unwavering judicial support in more than 20 proceedings.

Consulting a clinical ethics committee in such scenarios is both legally recommended and clinically warranted as an important device for diffusing tensions between relatives and clinicians, as well as clarifying their respective ethical and legal responsibilities.

In protracted or apparently irresolvable disputes with relatives, applying for a judicial declaration on futility of treatment has become a practical option for intensivists in Australia and should be a recognised part of their training.

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Centre:

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Assessing the Impact of the Australia-United States Free Trade Agreement (AUSFTA) on Australian and Global Medicines Policy

Author(s):

On 1 January 2005, a controversial trade agreement entered into force between Australia and the United States. Though heralded by the parties as facilitating the removal of barriers to free trade (in ways not achievable in multilateral fora), it also contained many trade-restricting intellectual property provisions and others uniquely related to altering pharmaceutical regulation and public health policy in Australia. The latter appear to have particularly focused on the world-respected process of federal government reimbursement after expert cost-effectiveness evaluation, popularly known as the Pharmaceutical Benefits Scheme ('PBS'). It remains uncertain what sort of impacts – if any – the Australia-United States Free Trade Agreement ('AUSFTA') will have on PBS processes such as reference pricing and their important role in facilitating equitable and affordable access to essential medicines. This is now the field of inquiry for a major three year Australian Research Council ('ARC')-funded study bringing together a team of senior researchers in regulatory theory from the Australian National University and pharmacoeconomics from the University of Newcastle. The project proposes to monitor, assess and analyse the real and potential impacts of the AUSFTA in this area, providing Australian policy-makers with continuing expertise and options. To the extent that the AUSFTA medicines provisions may represent an important precedent in a global strategy by industry on cost-effectiveness evaluation of pharmaceuticals, the study will also be of great interest to policy makers in other jurisdictions.

Read on SSRN

Centre:

Research theme:

Private Health Insurance and Regional Australia

Author(s):

Since 1996, an increasing proportion of federal government expenditure has been directed into Australia’s healthcare system via private health insurance (PHI) subsidies, in preference to Medicare and the direct funding of public health services.

• A central rationale for this policy shift is to increase the use of private hospital services and thereby reduce pressure on public inpatient facilities. However, the impact of this reform process on regional Australia has not been addressed.

• An analysis of previously unpublished Australian Bureau of Statistics data shows that regional Australians have substantially lower levels of private health fund membership. As a result, regional areas appear to be receiving substantially less federal government health funding, compared with cities, than if these funds were allocated on a per-capita basis.

• We postulate that the lower level of membership in regional areas is mainly due to the limited availability of private inpatient facilities, making PHI less attractive to rural Australians.

• We conclude that PHI as a vehicle for mainstream federal health financing has potential structural failures that disadvantage regional Australians.

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Centre:

Research theme:

Health Legislation: Interpretation Coherent with Conscience and International Human Rights

Author(s):

This essay seeks to explore some theoretical and practical obstacles to developing a coherent and comprehensive theory for the interpretation of health legislation. One obstacle considered involves the academic and professional reluctance to direct critical attention to interpretive actions outside the judicial sphere; in this case to those by health administrators, health professionals and patients. Another concerns a similar reticence to formally acknowledge the widespread utilization by such interpreters of principles derived from normative traditions distinct from many domestic legal systems, in particular those of medical ethics and international human rights. The third obstacle relates to the difficulties raised for interpretation of health legislation by community demands for greater transparency and quality assurance in the health care sector. Linked with this is the question whether interpretation of health legislation should be approached with a presumption that it promotes core social and professional virtues (such as justice, fairness and loyalty to relief of patient suffering) in the life narratives of those most directly affected.

Given existing presumptions that legislation will not seek to controvert basic principles of the common law or international law, it seems reasonable to for judiciary interprating an ambiguity to be required to presume that the relevant health legislation will not normally seek to overturn basic ethical principles of the doctor-patient relationship. Similarly justified would be a presumption that health legislation will not be interpreted to contravene basic ethical protections accorded research subjects through authoritative ethical codes and guidelines. Of like importance, as will be discussed, could be a rebuttable assumption that health legislation will not attempt to abrogate the primary fiduciary obligation and professional virtue of a doctor to remain loyal to the relief of suffering amongst his or her patients.

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Centre:

Research theme:

Global Intellectual Property Protection for Innovative Pharmaceuticals: Challenges for Bioethics and Health Law

Author(s):

Multilateral and bilateral trade agreements have become important vehicles by which US multinational corporations, through close collaboration with government officials, are striving, amongst other objectives, for increasingly stringent global intellectual property protection (GIPP), particularly over what they term “innovative” pharmaceuticals.

This chapter explores the evolution and structural dynamics of GIPP. It particularly considers the hypothesis that GIPP represents a corporate-driven ideology whose legitimacy in a democratic polity is undermined by its uncertain foundation in public health research and inadequate integration with norms of bioethics and health law, including international human rights.

This detailed analysis begins with consideration of the domestic evolution of GIPP from within the US patent system. This may reveal how many of its important structural features had their roots in a domestic profit-making ideology. The chapter then examines the critical initial globalization role of the US Trade Act 1974, particularly section 301. This permitted US industry to request an investigation by the US International Trade Commission of foreign nations whose practices allegedly caused it material injury. The Agreement on Trade Related Intellectual Property Rights (TRIPS) is analyzed as a mature component of GIPP by which increased intellectual property rights [intellectual monopoly privileges] in particular over pharmaceuticals, were linked with strong trade sanctions. The sophisticated contribution to GIPP made by the Medicare Prescription Drug Improvement and Modernization Act 2003 (US) is then evaluated, particularly its prohibition of Federal Government medicine price setting and its requirement for a study of pharmaceutical price controls in other developed countries. In each case the extent to which GIPP attempted or failed to integrate its corporate-designed principles with basic norms of bioethics, public health law and international human rights is discussed.

Read on SSRN

Centre:

Research theme:

Weapons of Mass Dispassion: James Hardie and Corporate Law

Author(s): Peta Spender

This lecture honours Michael Whincop's work by examining the controversy surrounding attempts by the James Hardie Group in 2004 to isolate its liability in tort to sufferers of asbestos disease. The lecture explores the absence of passion and compassion in corporate law, explains how it deflects moral claims and scrutinises the James Hardie imbroglio in a wider institutional and philosophical context.

Read on SSRN

Centre: CCL

Research theme: Law and Gender, Law and Social Justice, Private Law, Regulatory Law and Policy, The Legal Profession

Another Modest Proposal: In Defence of the Prohibition Against Torture

Author(s): Desmond Manderson

In response to political and legal events that took place in the years following 9/11, and to contemporary legal scholarship defending the use of torture or other methods of interrogation in situations of emergency and crisis, this essay defends the legal prohibition of torture by both empirical and philosophical means, moving back to Voltaire and Swift and forward to Iraq and Palestine in order to maintain the necessity and efficacy of the prohibition.

Read on SSRN

Centre: CLAH

Research theme: Legal Theory

Possessed: Drug Policy, Witchcraft and Belief

Author(s): Desmond Manderson

When our friends and family behave irrationally, indulging in fears and behaviours that even they agree are dysfunctional, eventually we stop reasoning with them and send them to an analyst instead. It is their irrational impulses that need to be understood if they are to change. After 50 years of prohibition, we know that banning heroin has not worked. Yet, still we persist. The question is why. It is time to psychoanalyse our drug policies, searching for the irrational fears and anxieties that lie at its heart. We find a surprisingly helpful parallel in another series of laws from long ago: the Witchcraft Laws of the sixteenth century. Entwining the two stories together, this essay argues that our drug laws are not intended to get rid of drugs, any more than the Inquisition wanted to ban the devil. The crime of possession is the sin of being possessed.

Read on SSRN

Centre: CLAH

Research theme: Legal Theory

Proximity – The Law of Ethics and the Ethics of Law

Author(s): Desmond Manderson

Emmanuel Levinas is one of the great writers on ethics of the 20th Century, but he is little known in law. His two main works, Totality and Infinity and Otherwise Than Being, or Beyond Essence, offer a reconstruction of human selfhood away from questions of identity and ego and towards an ‘ethics of the other’. His writing is passionate, mystical, and rational, at times erudite and elsewhere downright obtuse. But as reward for this struggle, Levinas offers a sustained meditation on the relationship of ethics, responsibility and law, and - remarkably - he does so using the language of the duty of care. Here then is a philosopher, largely unknown to legal theory, who at last speaks the language of torts. Central to Levinas’ meditations is an idea of ethics to which I will have recourse. For Levinas, and those who have been influenced by him, the word ethics implies a personal responsibility to another that is both involuntary and singular. The demand of ethics comes from the intimacy of an experienced encounter, and its contours cannot therefore be codified or predicted in advance. At least as opposed to the Kantian paradigm of morality as ‘a system of rules,’ ethics therefore speaks about inter-personal relationships and not about abstract principles. At least as opposed to most understandings of law, ethics insists on the necessity of our response to others, and the unique predicament of each such response, rather than attempting to reduce such responses to standard instances and norms of general application applicable to whole communities and capable of being settled in advance. Indeed, ethics constantly destabilizes and ruptures those rules and that settlement. Furthermore, ethics implies an unavoidable responsibility to another which Levinas exhorts as ‘first philosophy’: by this he means to indicate that without some such initial hospitality or openness to the vulnerability of another human being, neither language nor society nor law could ever have got going. At least as opposed to many understandings of justice, there is nothing logical or a priori inevitable about such an openness; except that without it, we would not be here to talk to one another. We cannot derive this ethics from rational first principles. Ethics is that first principle.

Read on SSRN

Centre: CLAH

Research theme: Legal Theory

Assessing the Impact of the Australia-United States Free Trade Agreement (AUSFTA) on Australian and Global Medicines Policy

Author(s):

On 1 January 2005, a controversial trade agreement entered into force between Australia and the United States. Though heralded by the parties as facilitating the removal of barriers to free trade (in ways not achievable in multilateral fora), it also contained many trade-restricting intellectual property provisions and others uniquely related to altering pharmaceutical regulation and public health policy in Australia. The latter appear to have particularly focused on the world-respected process of federal government reimbursement after expert cost-effectiveness evaluation, popularly known as the Pharmaceutical Benefits Scheme ('PBS'). It remains uncertain what sort of impacts – if any – the Australia-United States Free Trade Agreement ('AUSFTA') will have on PBS processes such as reference pricing and their important role in facilitating equitable and affordable access to essential medicines. This is now the field of inquiry for a major three year Australian Research Council ('ARC')-funded study bringing together a team of senior researchers in regulatory theory from the Australian National University and pharmacoeconomics from the University of Newcastle. The project proposes to monitor, assess and analyse the real and potential impacts of the AUSFTA in this area, providing Australian policy-makers with continuing expertise and options. To the extent that the AUSFTA medicines provisions may represent an important precedent in a global strategy by industry on cost-effectiveness evaluation of pharmaceuticals, the study will also be of great interest to policy makers in other jurisdictions.

Read on SSRN

Centre:

Research theme:

Fiduciary Disclosure of Medical Mistakes: The Duty to Promptly Notify Patients of Adverse Health Care Events

Author(s):

Fiduciary obligations are imposed by the common law to ensure that a person occupying a societal role with a high potential for the manipulation of vulnerable persons exercises utmost good faith. Australian law has recognised that the doctor-patient relationship, while not wholly fiduciary, has fiduciary aspects. Amongst such duties are those prohibiting sexual or financial abuse of patients or disclosure without express authority of confidential information. One important consequence of attaching such fiduciary duties to the doctor-patient relationship is that the onus of proof falls not upon the vulnerable party (the patient), but upon the doctor (to disprove the allegation). Another is that consent cannot be pleaded as an absolute defence. In this article the authors advocate that the law should now accept that the fiduciary obligations of the doctor-patient relationship extend to creating a legal duty that any adverse health care event be promptly reported to the patient involved. The reasons for creating such a presumption, as well as its elements and exceptions, are explained.

Read on SSRN

Centre:

Research theme:

'From this Time Forward... I Pledge My Loyalty to Australia': Loyalty, Citizenship and Constitutional Law in Australia

Author(s): Kim Rubenstein

A major change in Australian citizenship law occurred on 4 April 2002. On that day, the governor-general of Australia assented to the passage of the Australian Citizenship Amendment Act 2002 (Cth). Before that date, Australian citizens who took up a new citizenship (like Rupert Murdoch taking up US citizenship) automatically lost their Australian citizenship. Central to the former provision, and the 2002 changes, is a view of loyalty and allegiance to the nation-state. This chapter examines how those concepts of loyalty and allegiance are central to discussions on citizenship, and how they are reflected in Australian citizenship law. Moreover, it argues that the change on dual citizenship in Australia has constitutional ramifications; for example, section 44 of the Constitution prevents dual citizens from running for parliament. The chapter concludes with the proposal that the Constitution needs amendment to reflect modern notions of commitment over outdated notions of sole allegiance to one country.

Read on SSRN

Centre: CIPL, CLAH

Research theme: Administrative Law, Constitutional Law and Theory, Human Rights Law and Policy, Law and Gender, Legal History and Ethnology, Migration and Movement of Peoples

Jury Reform is Coming: Making the Most of Trial Practice Changes

Author(s): Molly Townes O'Brien

A nationwide movement to reform jury trial practice is underway. At the core of these reforms is an effort to make the courtroom more like a classroom. The current wave of jury reform is designed to take advantage of learning theory that shows that "active learners" remember and comprehend new information better than passive learners. Reforms in jury trial practice now being proposed across the country will allow jurors to take a more active role in the trial, to become "active learners" by allowing them to take notes, ask questions, discuss the evidence with each other, keep notebooks with exhibits and jury instructions, and more. The current wave of jury reform also gives attorneys more opportunities to address the jury and more opportunities to explain the merits of their case. The goal of the reforms is to improve jury comprehension and motivate the jurors to stay awake and attentive.

In general, reforms that treat the courtroom more like a classroom favor the lawyers who are the better teachers. Most trial lawyers already consider themselves to be good teachers. The "active learning" jury should motivate trial lawyers to pick up the chalk and plan to teach even more. Although students/jurors feel more empowered in an active learning environment, it is the person who has something to teach who is most empowered. The teacher is empowered because he or she has an audience that is attentive and better equipped with the tools to learn. The teacher/lawyer will see the reforms as new opportunities to reach into the jurors' minds. The skilled teacher/lawyer will guide note taking, provide excellent written materials for the juror notebooks, and use juror questions to gain insight about how the jurors' view the evidence. In other words, reforms designed to improve juror comprehension will, in the hands of a skilled teacher, give the trial lawyer more and better opportunities to teach and persuade the jury of the justice of their cause.

This short article will give you an overview of recent jury reform initiatives and provide some preliminary thoughts about how trial lawyers can make the most of the coming jury trial practice reforms.

Read on SSRN

Centre: CIPL, PEARL

Research theme: Criminal Law, Human Rights Law and Policy, Law and Social Justice, Legal Education

Global Intellectual Property Protection for Innovative Pharmaceuticals: Challenges for Bioethics and Health Law

Author(s):

Multilateral and bilateral trade agreements have become important vehicles by which US multinational corporations, through close collaboration with government officials, are striving, amongst other objectives, for increasingly stringent global intellectual property protection (GIPP), particularly over what they term “innovative” pharmaceuticals.

This chapter explores the evolution and structural dynamics of GIPP. It particularly considers the hypothesis that GIPP represents a corporate-driven ideology whose legitimacy in a democratic polity is undermined by its uncertain foundation in public health research and inadequate integration with norms of bioethics and health law, including international human rights.

This detailed analysis begins with consideration of the domestic evolution of GIPP from within the US patent system. This may reveal how many of its important structural features had their roots in a domestic profit-making ideology. The chapter then examines the critical initial globalization role of the US Trade Act 1974, particularly section 301. This permitted US industry to request an investigation by the US International Trade Commission of foreign nations whose practices allegedly caused it material injury. The Agreement on Trade Related Intellectual Property Rights (TRIPS) is analyzed as a mature component of GIPP by which increased intellectual property rights [intellectual monopoly privileges] in particular over pharmaceuticals, were linked with strong trade sanctions. The sophisticated contribution to GIPP made by the Medicare Prescription Drug Improvement and Modernization Act 2003 (US) is then evaluated, particularly its prohibition of Federal Government medicine price setting and its requirement for a study of pharmaceutical price controls in other developed countries. In each case the extent to which GIPP attempted or failed to integrate its corporate-designed principles with basic norms of bioethics, public health law and international human rights is discussed.

Read on SSRN

Centre:

Research theme:

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