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.

Access all

Access All was performance produced following a three-month mentorship in web-based performance that I was commissioned to conduct for the performance company Igneous. This live, triple-site performance event for three performers in three remote venues was specifically designed for presentation at Access Grid Nodes - conference rooms located around the globe equipped with a high end, open source computer teleconferencing technology that allowed multiple nodes to cross-connect with each other. Whilst each room was setup somewhat differently they all deployed the same basic infrastructre of multiple projectors, cameras, and sound as well as a reconfigurable floorspace. At that time these relatively formal setups imposed a clear series of limitations in terms of software capabilities and basic infrastructure and so there was much interest in understanding how far its capabilities might be pushed.----- Numerous performance experiments were undertaken between three Access Grid nodes in QUT Brisbane, VISLAB Sydney and Manchester Supercomputing Centre, England, culminating in the public performance staged simultaneously between the sites with local audiences at each venue and others online. Access All was devised in collaboration with interdisciplinary performance company Bonemap, Kelli Dipple (Interarts curator, Tate Modern London) and Mike Stubbs British curator and Director of FACT (Liverpool).----- This period of research and development was instigated and shaped by a public lecture I had earlier delivered in Sydney for the ‘Global Access Grid Network, Super Computing Global Conference’ entitled 'Performance Practice across Electronic Networks'. The findings of this work went on to inform numerous future networked and performative works produced from 2002 onwards.

Web-based public participatory GIS

Decision support systems (DSS) have evolved rapidly during the last decade from stand alone or limited networked solutions to online participatory solutions. One of the major enablers of this change is the fastest growing areas of geographical information system (GIS) technology development that relates to the use of the Internet as a means to access, display, and analyze geospatial data remotely. World-wide many federal, state, and particularly local governments are designing to facilitate data sharing using interactive Internet map servers. This new generation DSS or planning support systems (PSS), interactive Internet map server, is the solution for delivering dynamic maps and GIS data and services via the world-wide Web, and providing public participatory GIS (PPGIS) opportunities to a wider community (Carver, 2001; Jankowski & Nyerges, 2001). It provides a highly scalable framework for GIS Web publishing, Web-based public participatory GIS (WPPGIS), which meets the needs of corporate intranets and demands of worldwide Internet access (Craig, 2002). The establishment of WPPGIS provides spatial data access through a support centre or a GIS portal to facilitate efficient access to and sharing of related geospatial data (Yigitcanlar, Baum, & Stimson, 2003). As more and more public and private entities adopt WPPGIS technology, the importance and complexity of facilitating geospatial data sharing is growing rapidly (Carver, 2003). Therefore, this article focuses on the online public participation dimension of the GIS technology. The article provides an overview of recent literature on GIS and WPPGIS, and includes a discussion on the potential use of these technologies in providing a democratic platform for the public in decision-making.

Open access policies, practices and licensing : a review of the literature in Australia and selected jurisdictions

The full economic, cultural and environmental value of information produced or funded by the public sector can be realised through enabling greater access to and reuse of the information. To do this effectively it is necessary to describe and implement a policy framework that supports greater access and reuse among a distributed, online network of information suppliers and users. The objective of this study was to identify materials dealing with policies, principles and practices relating to information access and reuse in Australia and in other key jurisdictions internationally. Open Access Policies, Practices and Licensing: A review of the literature in Australia and selected jurisdictions sets out the findings of an extensive review of published materials dealing with policies, practices and legal issues relating to information access and reuse, with a particular focus on materials generated, held or funded by public sector bodies. The report was produced as part of the work program of the project “Enabling Real-Time Information Access in Both Urban and Regional Areas”, established within the Cooperative Research Centre for Spatial Information (CRCSI).

Paving pathways : shaping the public health workforce through tertiary education

Public health educational pathways in Australia have traditionally been the province of Universities, with the Master of Public Health (MPH) recognised as the flagship professional entry program. Public health education also occurs within the fellowship training of the Faculty of Public Health Medicine, but within Australia this remains confined to medical graduates. In recent years, however, we have seen a proliferation of undergraduate degrees as well as an increasing public health presence in the Vocational Education and Training (VET) sector. ----- Following the 2007 Australian Federal election, the new Labour government brought with it a refreshing commitment to a more inclusive and strategic style of government. An important example of this was the 2020 visioning process that identified key issues of public health concern, including an acknowledgment that it was unacceptable to allocate less than 2% of the health budget towards disease prevention. This led to the recommendation for the establishment of a national preventive health agency (Australia: the healthiest country by 2020 National Preventative Health Strategy, Prepared by the Preventative Health Taskforce 2009). ----- The focus on disease prevention places a spotlight on the workforce that will be required to deliver the new investment in health prevention, and also on the role of public health education in developing and upskilling the workforce. It is therefore timely to reflect on trends, challenges and opportunities from a tertiary sector perspective. Is it more desirable to focus education efforts on selected lead issues such as the “obesity epidemic”, climate change, Indigenous health and so on, or on the underlying theory and skills that build a flexible workforce capable of responding to a range of health challenges? Or should we aspire to both? ----- This paper presents some of the key discussion points from 2008 – 2009 of the Public Health Educational Pathways workshops and working group of the Australian Network of Public Health Institutions. We highlight some of the competing tensions in public health tertiary education, their impact on public health training programs, and the educational pathways that are needed to grow, shape and prepare the public health workforce for future challenges.

The application of the Park & Ride and TOD concepts to develop a new framework that can maximise public transport patronage

With growing concern over the use of the car in our urbanized society, there have emerged a number of lobby groups and professional bodies promoting a return to public transport, walking and cycling, with the urban village as the key driving land use, as a means of making our cities’ transportation systems more sustainable. This research has aimed at developing a framework applicable to the Australian setting that can facilitate increased passenger patronage of rail based urban transport systems from adjacent or associated land uses. The framework specifically tested the application of the Park & Ride and Transit Oriented Development (TOD) concepts and their applicability within the cultural, institutional, political and transit operational characteristics of Australian society. The researcher found that, although the application of the TOD concept had been limited to small pockets of town houses and mixed use developments around stations, the development industry and emerging groups within the community are posed to embrace the concept and bring with it increased rail patronage. The lack of a clear commitment to infrastructure and supporting land uses is a major barrier to the implementation of TODs. The research findings demonstrated significant scope for the size of a TOD to expand to a much greater radius of activity from the public transport interchange, than the commonly quoted 400 to 600 meters, thus incorporating many more residents and potential patrons. The provision of Park & Rides, and associated support facilities like Kiss & Rides, have followed worldwide trends of high patronage demands from the middle and outer car dependent suburbs of our cities. The data collection and analysis gathered by the researcher demonstrated that in many cases Park & Rides should form part of a TOD to ensure ease of access to rail stations by all modes and patron types. The question, however, remains how best to plan the incorporation of a Park & Ride within a TOD and still maintain those features that attract and promote TODs as a living entity.

Non-motorized public transport : a global review and analysis of trends and issues

Over recent decades there has been growing interest in the role of non-motorized modes in the overall transport system (especially walking and cycling for private purposes) and many government initiatives have been taken to encourage these active modes. However there has been relatively little research attention given to the paid form of non-motorized travel which can be called non-motorized public transport (NMPT). This involves cycle-powered vehicles which can carry several passengers (plus the driver) and a small amount of goods; and which provide flexible hail-and-ride services. Effectively they are non-motorized taxis. Common forms include cycle-rickshaw (Bangladesh, India), becak (Indonesia), cyclos (Vietnam, Cambodia), bicitaxi (Columbia, Cuba), velo-taxi (Germany, Netherland), and pedicabs (UK, Japan, USA). --------- The popularity of NMPT is widespread in developing countries, where it caters for a wide range of mobility needs. For instance in Dhaka, Bangladesh, rickshaws are the preferred mode for non-walk trips and have a higher mode share than cars or buses. Factors that underlie the continued existence and popularity of NMPT in many developing countries include positive contribution to social equity, micro-macro economic significance, employment creation, and suitability for narrow and crowded streets. Although top speeds are lower than motorized modes, NMPT is competitive and cost-effective for short distance door-to-door trips that make up the bulk of travel in many developing cities. In addition, NMPT is often the preferred mode for vulnerable groups such as females, children and elderly people. NMPT is more prominent in developing countries but its popularity and significance is also gradually increasing in several developed countries of Asia, Europe and parts of North America, where there is a trend for the NMPT usage pattern to broaden from tourism to public transport. This shift is due to a number of factors including the eco-sustainable nature of NMPT; its operating flexibility (such as in areas where motorized vehicle access is restricted or discouraged through pricing); and the dynamics that it adds to the urban fabric. Whereas NMPT may have been seen as a “dying” mode, in many cities it is maintaining or increasing its significance and with potential for further growth. --------- This paper will examine and analyze global trends in NMPT incorporating both developing and developed country contexts and issues such as usage patterns; NMPT policy and management practices; technological development; and operational integration of NMPT into the overall transport system. It will look at how NMPT policies, practices and usage have changed over time and the differing trends in developing and developed countries. In particular, it will use Dhaka, Bangladesh as a case study in recognition of its standing as the major NMPT city in the world. The aim is to highlight NMPT issues and trends and their significance for shaping future policy towards NMPT in developing and developed countries. The paper will be of interest to transport planners, traffic engineers, urban and regional planners, environmentalists, economists and policy makers.

Contesting ‘sustainability’ in infrastructure planning : The debate of the public interest in Brisbane’s Boggo Road Busway development

Sustainable infrastructure demands that declared principles of sustainability are enacted in the processes of its implementation. However, a problem arises if the concept of sustainability is not thoroughly scrutinised in the planning process. The public interest could be undermined when the rhetoric of sustainability is used to substantiate a proposed plan. This chapter analyses the manifestation of sustainable development in the Boggo Road Busway Plan in Brisbane, Australia against the sustainability agenda set in the South East Queensland Regional and Transport Plans. Although the construction of the Busway was intended to improve public transport access in the region, its implementation drew significant environmental concerns. Local community groups contested the ‘sustainability’ concept deployed in Queensland’s infrastructure planning. Their challenges resulted in important concessions in the delivery of the Busway plan. This case demonstrates that principles of sustainable infrastructure should be measurable and that local communities be better informed in order to fulfil the public interest in regional planning.

A secure framework and related protocols for ubiquitous access to electronic health records using Java sim cards

Ubiquitous access to patient medical records is an important aspect of caring for patient safety. Unavailability of sufficient medical information at the point-ofcare could possibly lead to a fatality. The U.S. Institute of Medicine has reported that between 44,000 and 98,000 people die each year due to medical errors, such as incorrect medication dosages, due to poor legibility in manual records, or delays in consolidating needed information to discern the proper intervention. In this research we propose employing emergent technologies such as Java SIM Cards (JSC), Smart Phones (SP), Next Generation Networks (NGN), Near Field Communications (NFC), Public Key Infrastructure (PKI), and Biometric Identification to develop a secure framework and related protocols for ubiquitous access to Electronic Health Records (EHR). A partial EHR contained within a JSC can be used at the point-of-care in order to help quick diagnosis of a patient’s problems. The full EHR can be accessed from an Electronic Health Records Centre (EHRC) when time and network availability permit. Moreover, this framework and related protocols enable patients to give their explicit consent to a doctor to access their personal medical data, by using their Smart Phone, when the doctor needs to see or update the patient’s medical information during an examination. Also our proposed solution would give the power to patients to modify the Access Control List (ACL) related to their EHRs and view their EHRs through their Smart Phone. Currently, very limited research has been done on using JSCs and similar technologies as a portable repository of EHRs or on the specific security issues that are likely to arise when JSCs are used with ubiquitous access to EHRs. Previous research is concerned with using Medicare cards, a kind of Smart Card, as a repository of medical information at the patient point-of-care. However, this imposes some limitations on the patient’s emergency medical care, including the inability to detect the patient’s location, to call and send information to an emergency room automatically, and to interact with the patient in order to get consent. The aim of our framework and related protocols is to overcome these limitations by taking advantage of the SIM card and the technologies mentioned above. Briefly, our framework and related protocols will offer the full benefits of accessing an up-to-date, precise, and comprehensive medical history of a patient, whilst its mobility will provide ubiquitous access to medical and patient information everywhere it is needed. The objective of our framework and related protocols is to automate interactions between patients, healthcare providers and insurance organisations, increase patient safety, improve quality of care, and reduce the costs.

A secure framework and related protocols for ubiquitous access to electronic health records using Java SIM cards

Ubiquitous access to patient medical records is an important aspect of caring for patient safety. Unavailability of sufficient medical information at the patient point-of-care could possibly lead to a fatality. In this paper we propose employing emergent technologies such as Java SIM Cards (JSC),Smart Phones (SP), Next Generation Networks (NGN), Near Field Communications (NFC), Public Key Infrastructure (PKI), and Biometric Identification to develop a secure framework and related protocols for ubiquitous access to Electronic Health Records (EHRs). A partial EHR contained within a JSC can be used at the patient point-of-care in order to help quick diagnosis of a patient’s problems. The full EHR can be accessed from an Electronic Healthcare Records Centre (EHRC).

Chronic disease, geographic location and socioeconomic disadvantage as obstacles to equitable access to e-health

Despite recent public attention to e-health as a solution to rising healthcare costs and an ageingpopulation, there have been relatively few studies examining the geographical pattern of e-health usage. This paper argues for an equitable approach to e-health and attention to the way in which e-health initiatives can produce locational health inequalities, particularly in socioeconomically disadvantaged areas. In this paper, we use a case study to demonstrate geographical variation in Internet accessibility, Internet status and prevalence of chronic diseases within a small district. There are signifi cant disparities in access to health information within socioeconomically disadvantaged areas. The most vulnerable people in these areas are likely to have limited availability of, or access to Internet healthcare resources. They are also more likely to have complex chronic diseases and, therefore, be in greatest need of these resources. This case study demonstrates the importance of an equitable approach to e-health information technologies and telecommunications infrastructure.

Support for gold open access publishing strategies at QUT

INTRODUCTION: Since the introduction of its QUT ePrints institutional repository of published research outputs, together with the world’s first mandate for author contributions to an institutional repository, Queensland University of Technology (QUT) has been a leader in support of green road open access. With QUT ePrints providing our mechanism for supporting the green road to open access, QUT has since then also continued to expand its secondary open access strategy supporting gold road open access, which is also designed to assist QUT researchers to maximise the accessibility and so impact of their research. ---------- METHODS: QUT Library has adopted the position of selectively supporting true gold road open access publishing by using the Library Resource Allocation budget to pay the author publication fees for QUT authors wishing to publish in the open access journals of a range of publishers including BioMed Central, Public Library of Science and Hindawi. QUT Library has been careful to support only true open access publishers and not those open access publishers with hybrid models which “double dip” by charging authors publication fees and libraries subscription fees for the same journal content. QUT Library has maintained a watch on the growing number of open access journals available from gold road open access publishers and their increased rate of success as measured by publication impact. ---------- RESULTS: This paper reports on the successes and challenges of QUT’s efforts to support true gold road open access publishers and promote these publishing strategy options to researchers at QUT. The number and spread of QUT papers submitted and published in the journals of each publisher is provided. Citation counts for papers and authors are also presented and analysed, with the intention of identifying the benefits to accessibility and research impact for early career and established researchers.---------- CONCLUSIONS: QUT Library is eager to continue and further develop support for this publishing strategy, and makes a number of recommendations to other research institutions, on how they can best achieve success with this strategy.

Can compensation be claimed under the standard commercial land and building contract where the property sold has no legally enforceable vehicular access?

This was the question that confronted Wilson J in Jarema Pty Ltd v Michihiko Kato [2004] QSC 451. Facts The plaintiff was the buyer of a commercial property at Bundall. The property comprised a 6 storey office building with a basement car park with 54 car parking spaces. The property was sold for $5 million with the contract being the standard REIQ/QLS form for Commercial Land and Buildings (2nd ed GST reprint). The contract provided for a “due diligence” period. During this period, the buyer’s solicitors discovered that there was no direct access from a public road to the car park entrance. Access to the car park was over a lot of which the Gold Coast City Council was the registered owner under a nomination of trustees, the Council holding the property on trust for car parking and town planning purposes. Due to the absence of a registered easement over the Council’s land, the buyer’s solicitors sought a reduction in the purchase price. The seller would not agree to this. Finally the sale was completed with the buyer reserving its rights to seek compensation.

Open content licensing of public sector information and the risk of tortious liability for Australian Governments

There has been an increasing interest by governments worldwide in the potential benefits of open access to public sector information (PSI). However, an important question remains: can a government incur tortious liability for incorrect information released online under an open content licence? This paper argues that the release of PSI online for free under an open content licence, specifically a Creative Commons licence, is within the bounds of an acceptable level of risk to government, especially where users are informed of the limitations of the data and appropriate information management policies and principles are in place to ensure accountability for data quality and accuracy.