Incentives for global public health: Patent law and access to essential medicines

This portrait of the global debate over patent law and access to essential medicines focuses on public health concerns about HIV/AIDS, malaria, tuberculosis, the SARS virus, influenza, and diseases of poverty. The essays explore the diplomatic negotiations and disputes in key international fora, such as the World Trade Organization, the World Health Organization and the World Intellectual Property Organization. Drawing upon international trade law, innovation policy, intellectual property law, health law, human rights and philosophy, the authors seek to canvass policy solutions which encourage and reward worthwhile pharmaceutical innovation while ensuring affordable access to advanced medicines. A number of creative policy options are critically assessed, including the development of a Health Impact Fund, prizes for medical innovation, the use of patent pools, open-source drug development and forms of 'creative capitalism'.

Access to essential medicines: Public health and international law

Historically, there have been intense conflicts over the ownership and exploitation of pharmaceutical drugs and diagnostic tests dealing with infectious diseases. Throughout the 1980’s, there was much scientific, legal, and ethical debate about which scientific group should be credited with the discovery of the human immunodeficiency virus, and the invention of the blood test devised to detect antibodies to the virus. In May 1983, Luc Montagnier, Françoise Barré-Sinoussi, and other French scientists from the Pasteur Institute in Paris, published a paper in Science, detailing the discovery of a virus called lymphadenopathy (LAV). A scientific rival, Robert Gallo of the National Cancer Institute, identified the AIDS virus and published his findings in the May 1984 issue of Science. In May 1985, the United States Patent and Trademark Office awarded the American patent for the AIDS blood test to Gallo and the Department of Health and Human Services. In December 1985, the Institut Pasteur sued the Department of Health and Human Services, contending that the French were the first to identify the AIDS virus and to invent the antibody test, and that the American test was dependent upon the French research. In March 1987, an agreement was brokered by President Ronald Reagan and French Prime Minister Jacques Chirac, which resulted in the Department of Health and Human Services and the Institut Pasteur sharing the patent rights to the blood test for AIDS. In 1992, the Federal Office of Research Integrity found that Gallo had committed scientific misconduct, by falsely reporting facts in his 1984 scientific paper. A subsequent investigation by the National Institutes of Health, the United States Congress, and the US attorney-general cleared Gallo of any wrongdoing. In 1994, the United States government and French government renegotiated their agreement regarding the AIDS blood test patent, in order to make the distribution of royalties more equitable... The dispute between Luc Montagnier and Robert Gallo was not an isolated case of scientific rivalry and patent races. It foreshadowed further patent conflicts over research in respect of HIV/AIDS. Michael Kirby, former Justice of the High Court of Australia diagnosed a clash between two distinct schools of philosophy - ‘scientists of the old school... working by serendipity with free sharing of knowledge and research’, and ‘those of the new school who saw the hope of progress as lying in huge investments in scientific experimentation.’ Indeed, the patent race between Robert Gallo and Luc Montagnier has been a precursor to broader trade disputes over access to essential medicines in the 1990s and 2000s. The dispute between Robert Gallo and Luc Montagnier captures in microcosm a number of themes of this book: the fierce competition for intellectual property rights; the clash between sovereign states over access to medicines; the pressing need to defend human rights, particularly the right to health; and the need for new incentives for research and development to combat infectious diseases as both an international and domestic issue.

Beyond charity : outlines of a jurisprudence for civil society

There is not a single, coherent, jurisprudence for civil society organisations. Pressure for a clearly enuciated body of law applying to the whole of this sector of society continues to increase. The rise of third sector scholarship, the retreat of the welfare state, the rediscovery of the concept of civil society and pressures to strengthen social capital have all contributed to an ongoing stream of inquiry into the laws that regulate and favour civil society organisations. There have been almost thirty inquiries over the last sixty years into the doctrine of charitable purpose in common law countries. Those inquiries have established that problems with the law applying to civil society organisations are rooted in the common law adopting a ‘technical’ definition of charitable purpose and the failure of this body of law to develop in response to societal changes. Even though it is now well recognised that problems with law reform stem from problems inherent in the doctrine of charitable purpose, statutory reforms have merely ‘bolted on’ additions to the flawed ‘technical’ definition. In this way the scope of operation of the law has been incrementally expanded to include a larger number of civil society organisations. This piecemeal approach continues the exclusion of most civil society organisations from the law of charities discourse, and fails to address the underlying jurisprudential problems. Comprehensive reform requires revisiting the foundational problems embedded in the doctrine of charitable purpose, being informed by recent scholarship, and a paradigm shift that extends the doctrine to include all civil society organisations. Scholarly inquiry into civil society organisations, particularly from within the discipline of neoclassical economics, has elucidated insights that can inform legal theory development. This theory development requires decoupling the two distinct functions performed by the doctrine of charitable purpose which are: setting the scope of regulation, and determining entitlement to favours, such as tax exemption. If the two different functions of the doctrine are considered separately in the light of theoretical insights from other disciplines, the architecture for a jurisprudence emerges that facilitates regulation, but does not necessarily favour all civil society organisations. Informed by that broader discourse it is argued that when determining the scope of regulation, civil society organisations are identified by reference to charitable purposes that are not technically defined. These charitable purposes are in essence purposes which are: Altruistic, for public Benefit, pursued without Coercion. These charitable puposes differentiate civil society organisations from organisations in the three other sectors namely; Business, which is manifest in lack of altruism; Government, which is characterised by coercion; and Family, which is characterised by benefits being private not public. When determining entitlement to favour, it is theorised that it is the extent or nature of the public benefit evident in the pursuit of a charitable purpose that justifies entitlement to favour. Entitlement to favour based on the extent of public benefit is the theoretically simpler – the greater the public benefit the greater the justification for favour. To be entitled to favour based on the nature of a purpose being charitable the purpose must fall within one of three categories developed from the first three heads of Pemsel’s case (the landmark categorisation case on taxation favour). The three categories proposed are: Dealing with Disadvantage, Encouraging Edification; and Facilitating Freedom. In this alternative paradigm a recast doctrine of charitable purpose underpins a jurisprudence for civil society in a way similar to the way contract underpins the jurisprudence for the business sector, the way that freedom from arbitrary coercion underpins the jurisprudence of the government sector and the way that equity within families underpins succession and family law jurisprudence for the family sector. This alternative architecture for the common law, developed from the doctrine of charitable purpose but inclusive of all civil society purposes, is argued to cover the field of the law applying to civil society organisations and warrants its own third space as a body of law between public law and private law in jurisprudence.

Legislating for sustainability: a framework for managing statutory rights obligations and restrictions affecting private land

The ad hoc growth of administrative controls on land use has produced an information management problem. Land registries face growing demands to record on the Torrens register particulars of rights, obligations and restrictions created under public law statutes, in order to reduce information costs, promote compliance and inform planning. As sustainable management of land and natural resources will require more legislative regulation, this paper proposes a framework of principles for the more coherent and consistent management of public law controls on private land use.

Government community service contracts : restraining abuse of power

The use of grant contracts to deliver community services is now a significant feature of all Australian government administrations. These contracts are the primary instrument governing the provision of such services to citizens and are largely outside the usual parliamentary review mechanisms and constraints. This article examines the extent of the erosion of fundamental constitutional principles facilitated by the use of private contracts, by applying the principles used in scrutiny of delegated legislation to standard form federal and State community service contracts. It reveals extensive executive power which, if the relationship were founded in legislative instruments rather than in private contract, would have to be justified to Parliament at least and possibly not tolerated.

Integrity, attribution, and exploitation : contractual and normative moral rights protection in open licensing

Over the last twenty years, the use of open content licenses has become increasingly and surprisingly popular. The use of such licences challenges the traditional incentive-based model of exclusive rights under copyright. Instead of providing a means to charge for the use of particular works, what seems important is mitigating against potential personal harm to the author and, in some cases, preventing non-consensual commercial exploitation. It is interesting in this context to observe the primacy of what are essentially moral rights over the exclusionary economic rights. The core elements of common open content licences map somewhat closely to continental conceptions of the moral rights of authorship. Most obviously, almost all free software and free culture licences require attribution of authorship. More interestingly, there is a tension between social norms developed in free software communities and those that have emerged in the creative arts over integrity and commercial exploitation. For programmers interested in free software, licence terms that prohibit commercial use or modification are almost completely inconsistent with the ideological and utilitarian values that underpin the movement. For those in the creative industries, on the other hand, non-commercial terms and, to a lesser extent, terms that prohibit all but verbatim distribution continue to play an extremely important role in the sharing of copyright material. While prohibitions on commercial use often serve an economic imperative, there is also a certain personal interest for many creators in avoiding harmful exploitation of their expression – an interest that has sometimes been recognised as forming a component of the moral right of integrity. One particular continental moral right – the right of withdrawal – is present neither in Australian law or in any of the common open content licences. Despite some marked differences, both free software and free culture participants are using contractual methods to articulate the norms of permissible sharing. Legal enforcement is rare and often prohibitively expensive, and the various communities accordingly rely upon shared understandings of acceptable behaviour. The licences that are commonly used represent a formalised expression of these community norms and provide the theoretically enforceable legal baseline that lends them legitimacy. The core terms of these licences are designed primarily to alleviate risk in sharing and minimise transaction costs in sharing and using copyright expression. Importantly, however, the range of available licences reflect different optional balances in the norms of creating and sharing material. Generally, it is possible to see that, stemming particularly from the US, open content licences are fundamentally important in providing a set of normatively accepted copyright balances that reflect the interests sought to be protected through moral rights regimes. As the cost of creation, distribution, storage, and processing of expression continues to fall towards zero, there are increasing incentives to adopt open content licences to facilitate wide distribution and reuse of creative expression. Thinking of these protocols not only as reducing transaction costs but of setting normative principles of participation assists in conceptualising the role of open content licences and the continuing tensions that permeate modern copyright law.

The paradigm shift in realising the right to read : how ebook libraries are enabling in the university sector

Millions of people with print disabilities are denied the right to read. While some important efforts have been made to convert standard books to accessible formats and create accessible repositories, these have so far only addressed this crisis in an ad hoc way. This article argues that universally designed ebook libraries have the potential of substantially enabling persons with print disabilities. As a case study of what is possible, we analyse 12 academic ebook libraries to map their levels of accessibility. The positive results from this study indicate that universally designed ebooks are more than possible; they exist. While results are positive, however, we also found that most ebook libraries have some features that frustrate full accessibility, and some ebook libraries present critical barriers for people with disabilities. Based on these findings, we consider that some combination of private pressure and public law is both possible and necessary to advance the right-to-read cause. With access improving and recent advances in international law, now is the time to push for universal design and equality.

Hamcor Pty Ltd v Queensland

The Ipp Report recommendation that for claims for personal injury and death arising from the negligent performance or non-performance of a public function based upon a policy decision, could not establish negligence unless the public authority was so unreasonable that no reasonable public authority in the same position would have made it, was adopted in different ways by all jurisdictions except South Australia and the Northern Territory.1 This introduced the public law concept of Wednesbury unreasonableness to civil liability which caused much academic debate.2 Section 36 of the Queensland provides...

Traceability : retracing law and public policy on measurement standards

This presentation outlines key aspects of public policy in broad terms insofar as they relate to establishment, implementation and compliance with legal measurement standards. It refers in particular to traceability of a legal measurement unit from its source in a single international standard as a compliance issue. It comments on accreditation of legal measurement and liability concerned with errors in measurement.

Access to public sector information : law, technology and policy

On the back of the growing capacity of networked digital information technologies to process and visualise large amounts of information in a timely, efficient and user-driven manner we have seen an increasing demand for better access to and re-use of public sector information (PSI). The story is not a new one. Share knowledge and together we can do great things; limit access and we reduce the potential for opportunity. The two volumes of this book seek to explain and analyse this global shift in the way we manage public sector information. In doing so they collect and present papers, reports and submissions on the topic by leading authors and institutions from across the world. These in turn provide people tasked with mapping out and implementing information policy with reference material and practical guidance. Volume 1 draws together papers on the topic by policymakers, academics and practitioners while Volume 2 presents a selection of the key reports and submissions that have been published over the last few years.

Impact of the Corporate Law Economic Reform Program Act 1999 on initial public offering prospectus earnings forecasts

Commencing 13 March 2000, the Corporate Law Economic Reform Program Act 1999 (Cth) introduced changes to the regulation of corporate fundraising in Australia. In particular, it effected a reduction in the litigation risk associated with initial public offering prospectus disclosure.We find that the change is associated with a reduction in forecast frequency and an increase in forecast value relevance, but not with forecast error or bias. These results confirm previous findings that changes in litigation risk affect the level but not the quality of disclosure. They also suggest that the reforms’ objectives of reducing fundraising costs while improving investor protection, have been achieved.

The rule of law, the public interest and the management of natural resources in Australia

The statutory arrangements for the management of natural resources in Australia confer powers of decision-making upon government agencies and, at the same time, restrict how these powers are to be exercised by reference either to stated criteria or in some instances to the public interest. These restrictions perform different functions according to their structure, form and language: for example they may be in the form of jurisdictional, deliberative or purposive rules. This article reviews how the offshore resources legislation of the Commonwealth and some examples of the onshore resources legislation of Queensland address the functions performed by the public interest in determining whether there is compliance with the principle of the rule of law.