Turing and the Trans-Pacific Partnership: Intellectual Property, Public Health, and Access to Essential Medicines

A recent controversy in the United States over drug pricing by Turing Pharmaceuticals AG has raised larger issues in respect of intellectual property, access to medicines, and the Trans-Pacific Partnership (TPP). In August 2015, Turing Pharmaceuticals AG – a private biopharmaceutical company with offices in New York, the United States, and Zug, Switzerland - acquired the exclusive marketing rights to Daraprim in the United States from Impax Laboratories Incorporated. Martin Shkreli, Turing’s Founder and Chief Executive Officer, maintained: “The acquisition of Daraprim and our toxoplasmosis research program are significant steps along Turing’s path of bringing novel medications to patients with serious disorders, some of whom often go undiagnosed and untreated.” He emphasised: “We intend to invest in the development of new drug candidates that we hope will yield an even better clinical profile, and also plan to launch an educational effort to help raise awareness and improve diagnosis for patients with toxoplasmosis.” In September 2015, there was much public controversy over the decision of Martin Shkreli to raise the price of a 62 year old drug, Daraprim, from $US13.50 to $US750 a pill. The drug is particularly useful in respect to the treatment and prevention of malaria, and in the treatment of infections in individuals with HIV/AIDS. Daraprim is listed on the World Health Organization’s (WHO) List of Essential Medicines. In the face of much criticism, Martin Shkreli has said that he will reduce the price of Daraprim. He observed: “We've agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit.” He maintained: “We think these changes will be welcomed.” However, he has been vague and ambiguous about the nature of the commitment. Notably, the lobby group, Pharmaceutical Research and Manufacturers of America (PhARMA), disassociated itself from the claims of Turing Pharmaceuticals. The group said: “PhRMA members have a long history of drug discovery and innovation that has led to increased longevity and improved lives for millions of patients.” The group noted: “Turing Pharmaceutical is not a member of PhRMA and we do not embrace either their recent actions or the conduct of their CEO.” The biotechnology peak body Biotechnology Industry Organization also sought to distance itself from Turing Pharmaceuticals. A hot topic: United States political debate about access to affordable medicines This controversy over Daraprim is unusual – given the age of drug concerned. Daraprim is not subject to patent protection. Nonetheless, there remains a monopoly in respect of the marketplace. Drug pricing is not an isolated problem. There have been many concerns about drug pricing – particularly in respect of essential medicines for HIV/AIDS, tuberculosis, and malaria. This recent controversy is part of a larger debate about access to affordable medicines. The dispute raises larger issues about healthcare, consumer rights, competition policy, and trade. The Daraprim controversy has provided impetus for law reform in the US. US Presidential Candidate Hillary Clinton commented: “Price gouging like this in this specialty drug market is outrageous.” In response to her comments, the Nasdaq Biotechnology Index fell sharply. Hillary Clinton has announced a prescription drug reform plan to protect consumers and promote innovation – while putting an end to profiteering. On her campaign site, she has emphasised that “affordable healthcare is a basic human right.” Her rival progressive candidate, Bernie Sanders, was also concerned about the price hike. He wrote a letter to Martin Shkreli, complaining about the price increase for the drug Daraprim. Sanders said: “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications.” He has pushed for reforms to intellectual property to make medicines affordable. The TPP and intellectual property The Daraprim controversy and political debate raises further issues about the design of the TPP. The dispute highlights the dangers of extending the rights of pharmaceutical drug companies under intellectual property, investor-state dispute settlement, and drug administration. Recently, the civil society group Knowledge Ecology International published a leaked draft of the Intellectual Property Chapter of the TPP. Knowledge Ecology International Director, James Love, was concerned the text revealed that the US “continues to be the most aggressive supporter of expanded intellectual property rights for drug companies.” He was concerned that “the proposals contained in the TPP will harm consumers and in some cases block innovation.” James Love feared: “In countless ways, the Obama Administration has sought to expand and extend drug monopolies and raise drug prices.” He maintained: “The astonishing collection of proposals pandering to big drug companies make more difficult the task of ensuring access to drugs for the treatment of cancer and other diseases and conditions.” Love called for a different approach to intellectual property and trade: “Rather than focusing on more intellectual property rights for drug companies, and a death-inducing spiral of higher prices and access barriers, the trade agreement could seek new norms to expand the funding of medical research and development (R&D) as a public good, an area where the US has an admirable track record, such as the public funding of research at the National Institutes of Health (NIH) and other federal agencies.” In addition, there has been much concern about the Investment Chapter of the TPP. The investor-state dispute settlement regime would enable foreign investors to challenge government policy making, which affected their investments. In the context of healthcare, there is a worry that pharmaceutical drug companies will deploy their investor rights to challenge public health measures – such as, for instance, initiatives to curb drug pricing and profiteering. Such concerns are not merely theoretical. Eli Lilly has brought an investor action against the Canadian Government over the rejection of its drug patents under the investor-state dispute settlement regime of the North American Free Trade Agreement (NAFTA). The Health Annex to the TPP also raises worries that pharmaceutical drug companies will able to object to regulatory procedures in respect of healthcare. It is disappointing that the TPP – in the leaks that we have seen – has only limited recognition of the importance of access to essential medicines. There is a need to ensure that there are proper safeguards to provide access to essential medicines – particularly in respect of HIV/AIDs, malaria, and tuberculosis. Moreover, there must be protection against drug profiteering and price gouging in any trade agreement. There should be strong measures against the abuse of intellectual property rights. The dispute over Turing Pharmaceuticals AG and Daraprim is an important cautionary warning in respect of some of the dangers present in the secret negotiations in respect of the TPP. There is a need to preserve consumer rights, competition policy, and public health in trade negotiations over an agreement covering the Pacific Rim.

Now the real international fight begins for the Trans-Pacific Partnership

In Atlanta, the trade ministers of a dozen countries across the Pacific Rim announced that they had successfully reached a concluded agreement upon the Trans-Pacific Partnership. The debate over the TPP will now play out in legislatures across the Pacific Rim, where sentiment towards the deal is much more mixed. The ministers insisted: “After more than five years of intensive negotiations, we have come to an agreement that will support jobs, drive sustainable growth, foster inclusive development, and promote innovation across the Asia-Pacific region … The agreement achieves the goal we set forth of an ambitious, comprehensive, high standard and balanced agreement that will benefit our nation’s citizens … We expect this historic agreement to promote economic growth, support higher-paying jobs; enhance innovation, productivity and competitiveness; raise living standards; reduce poverty in our countries; and to promote transparency, good governance, and strong labor and environmental protections.” But there has been fierce criticism of the Trans-Pacific Partnership, because of both its secrecy and its substance. Nobel Laureate Professor Joseph Stiglitz has warned that the agreement is not about free trade, but about the protection of corporate monopolies. The intellectual property chapter provides for longer and stronger protection of intellectual property rights. The investment chapter provides foreign investors with the power to challenge governments under an investor-state dispute settlement (ISDS) regime. The environment chapter is weak and toothless, and seems to be little more than an exercise in greenwashing. The health annex — and many other parts of the agreement — strengthen the power of pharmaceutical companies and biotechnology developers. The text on state-owned enterprises raises concerns about public ownership of postal services, broadcasters and national broadband services.

The Trans-Pacific partnership protects old companies at the expense of the new

Under this trade agreement, intellectual property will be transformed into a means of protecting the investments of multinational companies in culture, advertising, and medicine, writes Matthew Rimmer. The Trans-Pacific Partnership (TPP) is a blockbuster trade deal, which will transform the intellectual property of the Pacific Rim. The Australian Prime Minister Malcolm Turnbull has argued the trade agreement is a "gigantic foundation stone" for the country's future prosperity. Nonetheless, though the final text remains unreleased, it's clear from what we do know that the Intellectual Property Chapter is set to protect legacy intellectual property industries - rather than support disruptive technologies and dynamic innovation.

The legal framework of the Australian health system

This chapter is about the role of law in the creation and operation of Australian health systems. Accordingly, this chapter discusses how law regulates the way in which health services in Australia are funded, organised, regulated, managed, operated and governed. (The question of how health professionals are regulated is discussed in Chapter 15.) Although the focus of much of health law is on legal mechanisms for the resolution of disputes or disagreements between the state, health providers, professionals, patients and families and friends, and through dispute resolutions processes setting standards for practice, these are only some of the “jobs” that health law performs. In health systems where the state undertakes a significant role in regulating, funding, managing and providing health services, health law also performs an important constitutive function. Health law declares the values upon which the health system is based, shapes social processes to achieve public ends and provides a structure for the complex interactions that occur within a modern health system. Health law regulates decision-makers in health systems by establishing who has the power to participate in decisions and in what circumstances, establishing processes through which decisions are made and creating mechanisms for decision-makers to be held publicly accountable. It is this broader constitutive function of health law that is a primary focus of much of this chapter — how and why governments use their legislative powers to structure and shape the health system.

The Australian Nonprofit Sector Legal Almanac 2015

Collected summaries of court cases involving nonprofit organisations, from Australia and overseas, during 2015, along with updates of legislative changes in all Australian jurisdictions. Significant Australian cases included several disputes with State Revenue Authorities about exemption from payroll taxes.

Regulating Multi-National Corporations Through State-Based Laws : Problems with Enforcing Human Rights Under The Alien Tort Statute

Under the Alien Tort Statute United States of America (“America”) Federal Courts have the jurisdiction to hear claims for civil wrongs, committed against non-American citizens, which were perpetrated outside America’s national borders. The operation of this law has confronted American Federal Courts with difficulties on how to manage conflicts between American executive foreign policy and judicial interpretations of international law. Courts began to pass judgment over conduct which was approved by foreign governments. Then in 2005 the American Supreme Court wound back the scope of the Alien Tort Statute. This article will review the problems with the expansion of the Alien Tort Statute and the reasons for its subsequent narrowing.

Teachers reporting suspected child sexual abuse : results of a three-state study

Over 3000 cases of child sexual abuse are identified every year in Australia, but the real incidence is higher still. As a strategy to identify child sexual abuse, Australian States and Territories have enacted legislation requiring members of selected professions, including teachers, to report suspected cases. In addition, policy-based reporting obligations have been developed by professions, including the teaching profession. These legislative and industry-based developments have occurred in a context of growing awareness of the incidence and consequences of child sexual abuse. Teachers have frequent contact and close relationships with children, and possess expertise in monitoring changes in children’s behaviour. Accordingly, teachers are seen as being well-placed to detect and report suspected child sexual abuse. To date, however, there has been little empirical research into the operation of these reporting duties. The extent of teachers’ awareness of their duties to report child sexual abuse is unknown. Further, there is little evidence about teachers’ past reporting practice. Teachers’ duties to report sexual abuse, especially those in legislation, differ between States, and it is not known whether or how these differences affect reporting practice. This article presents results from the first large-scale Australian survey of teachers in three States with different reporting laws: New South Wales, Queensland, and Western Australia. The results indicate levels of teacher knowledge of reporting duties, reveal evidence about past reporting practice, and provide insights into anticipated future reporting practice and legal compliance. The findings have implications for reform of legislation and policy, training of teachers about the reporting of child sexual abuse, and enhancement of child protection.

International labour standards and Queensland

Queensland’s legal labour disputes history does not exhibit the current trend seen in Canada and Switzerland (Gravel & Delpech, 2008) where cases citing International Labour Standards (ILS) are often successful (which is not presently the case in Queensland either). The two Queensland cases (Kuhler v. Inghams Enterprises P/L & Anor, 1997 and Bale v. Seltsam Pty Ltd, 1996) that have used ILSs were lost. Australia is a member state of the International Labour Organization (ILO) and a signatory of many ILSs. Yet, ILSs are not used in their legal capacity when compared to other international standards in other areas of law. It is important to recognize that ILSs are uniquely underutilized in labour law. Australian environmental, criminal, and industrial disputes consistently draw on international standards. Why not for the plight of workers? ILSs draw their power from supranational influence in that when a case cites an ILS the barrister or solicitor is going beyond legal precedence and into international peer pressure. An ILS can be appropriately used to highlight that Australian or Queensland legislation does not conform to a Convention or Recommendation. However, should the case deal with a breach of existing law based or modified by an ILS, citing the ILS is a good way to remind the court of its origin. It’s a new legal paradigm critically lacking in Queensland’s labour law practice. The following discusses the research methodology used in this paper. It is followed by a comparative discussion of results between the prevalence of ILSs and other international standards in Queensland case history. Finally, evidence showing the international trend of labour disputes using ILSs for victory is discussed.

Some critical legal issues affecting insurance transaction globally

Increasingly, major insurers and reinsurers are operating on a global basis. For example, General Re Corporation and Cologne Re operate in almost 150 countries : see "General Re Corporation 1999 Annual Report". This is also true for the world's major brokers, and the emergence of large broking conglomerates such as Aon and Marsh are good examples of global service providers. Against the background of this increasingly global insurance market with global participants, there are a range of common legal issues in this article but a selection of certain critical matters are canvassed in the secitons below. First there are a range of regulatory issues that must be addressed. Secondly globalisation of the industry does create added incentive for a common legal regime to cover the formation of insurance transactions and the resolution of disputes about claims, coverage and termination. In this contect codifcation of insurance laws is a critical issue. Thirdly, major advances in genetic research and biotechnology over recent years have resulted in a dramatic increase in the availability of genetic testing. These developments have given rise to concerns worldwide about the potential for misuse of genetic information by third parties such as insurers and employers. Fourthly, the essence of an insurance transaction is the transference of risk from one person to anther. It is generally accepted that this transference should occur in informed circumstances and without undue advantage being bestowed upon either party. Finally this article will consider some legal matter in relation to transacting insurance on the internet

A quite unreasonable state of affairs : corporate social responsibility and the John Lewis Partnership

On the surface the subjects of Corporate Social Responsibility (CSR) and Critical Management Studies (CMS) seem to be closely related. Both are concerned with reflecting on the impact of management and organisation on employees, the wider community and the environment. Both suggest that there may be a need for organisations to take responsibility for and account of people other than shareholders and both have used the concept of accountability to suggest that organisations may need to do more than just comply with the legal framework.

If it's encrypted it's secure! The viability of US state-based encryption exemptions

US state-based data breach notification laws have unveiled serious corporate and government failures regarding the security of personal information. These laws require organisations to notify persons who may be affected by an unauthorized acquisition of their personal information. Safe harbours to notification exist if personal information is encrypted. Three types of safe harbour have been identified in the literature: exemptions, rebuttable presumptions and factors. The underlying assumption of exemptions is that encrypted personal information is secure and therefore unauthorized access does not pose a risk. However, the viability of this assumption is questionable when examined against data breaches involving encrypted information and the demanding practical requirements of effective encryption management. Recent recommendations by the Australian Law Reform Commission (ALRC) would amend the Privacy Act 1988 (Cth) to implement a data breach scheme that includes a different type of safe harbour, factor based analysis. The authors examine the potential capability of the ALRC’s proposed encryption safe harbour in relation to the US experience at the state legislature level.

Australian data breach notification : avoiding the State/Federal overlap

Mandatory data breach notification has become a matter of increasing concern for law reformers. In Australia, this issue was recently addressed as part of a comprehensive review of privacy law conducted by the Australian Law Reform Commission (ALRC) which recommended a uniform national regime for protecting personal information applicable to both the public and private sectors. As in all federal systems, the distribution of powers between central and state governments poses problems for national consistency. In the authors’ view, a uniform approach to mandatory data breach notification has greater merit than a ‘jurisdiction specific’ approach epitomized by US state-based laws. The US response has given rise to unnecessary overlaps and inefficiencies as demonstrated by a review of different notification triggers and encryption safe harbors. Reviewing the US response, the authors conclude that a uniform approach to data breach notification is inherently more efficient.

Legal responses to climate change

The challenges of climate change pose problems requiring new and innovative legal responses by legal practitioners, government officials and corporate officers. This book addresses a broad range of topic areas where climate change has impact and systematically analyses the key legal responses to climate change, both at the international level and within Australia at federal, State and local levels. In particular, it critically examines: •the rights, duties and market mechanisms established under the international climate change regime •the effect of climate change policies on the implementation of environmental and planning laws •new regimes for the implementation of renewable energy and energy efficiency initiatives •legal frameworks for the implementation of biological and geological sequestration projects (including forest projects and carbon rights); and •legal principles for the design of an effective carbon trading scheme for Australia It also considers the role of the common law including: •the likely response of the law of torts to emerging forms of climate change harm; and •potential liabilities for professionals who must take climate change into account in their decision-making and advice

The legal role of medical professionals in decisions to withhold or withdraw life-sustaining treatment : Part 1 (New South Wales)

This is the first article in a series of three that examines the legal role of medical professionals in decisions to withhold or withdraw life-sustaining treatment from adults who lack capacity. This article considers the position in New South Wales. A review of the law in this State reveals that medical professionals play significant legal roles in these decisions. However, the law is problematic in a number of respects and this is likely to impede medical professionals’ legal knowledge in this area. The article examines the level of training medical professionals receive on issues such as advance directives and substitute decision-making, and the available empirical evidence as to the state of medical professionals’ knowledge of the law at the end of life. It concludes that there are gaps in legal knowledge and that law reform is needed in New South Wales.