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.

Particle number and mass emission factors from combustion of wood samples collected from Queensland forest

Knowledge of particle emission characteristics associated with forest fires and in general, biomass burning, is becoming increasingly important due to the impact of these emissions on human health. Of particular importance is developing a better understanding of the size distribution of particles generated from forest combustion under different environmental conditions, as well as provision of emission factors for different particle size ranges. This study was aimed at quantifying particle emission factors from four types of wood found in South East Queensland forests: Spotted Gum (Corymbia citriodora), Red Gum (Eucalypt tereticornis), Blood Gum (Eucalypt intermedia), and Iron bark (Eucalypt decorticans); under controlled laboratory conditions. The experimental set up included a modified commercial stove connected to a dilution system designed for the conditions of the study. Measurements of particle number size distribution and concentration resulting from the burning of woods with a relatively homogenous moisture content (in the range of 15 to 26 %) and for different rates of burning were performed using a TSI Scanning Mobility Particle Sizer (SMPS) in the size range from 10 to 600 nm and a TSI Dust Trak for PM2.5. The results of the study in terms of the relationship between particle number size distribution and different condition of burning for different species show that particle number emission factors and PM2.5 mass emission factors depend on the type of wood and the burning rate; fast burning or slow burning. The average particle number emission factors for fast burning conditions are in the range of 3.3 x 1015 to 5.7 x 1015 particles/kg, and for PM2.5 are in the range of 139 to 217 mg/kg.

A Short History of Cultural Studies (Taiwanese edition)

This is the first volume to capture the essence of the burgeoning field of cultural studies in a concise and accessible manner. Other books have explored the British and North American traditions, but this is the first guide to the ideas, purposes and controversies that have shaped the subject. The author sheds new light on neglected pioneers and a clear route map through the terrain. He provides lively critical narratives on a dazzling array of key figures including, Arnold, Barrell, Bennett, Carey, Fiske, Foucault, Grossberg, Hall, Hawkes, hooks, Hoggart, Leadbeater, Lissistzky, Malevich, Marx, McLuhan, McRobbie, D Miller, T Miller, Morris, Quiller-Couch, Ross, Shaw, Urry, Williams, Wilson, Wolfe and Woolf. Hartley also examines a host of central themes in the subject including literary and political writing, publishing, civic humanism, political economy and Marxism, sociology, feminism, anthropology and the pedagogy of cultural studies.

Governance and effectiveness in regional planning: an analysis of North American, European, and Australasian practice

Over the past several years, there has been resurgent interest in regional planning in North America, Europe and Australasia. Spurred by issues such as metropolitan growth, transportation infrastructure, environmental management and economic development, many states and metropolitan regions are undertaking new planning initiatives. These regional efforts have also raised significant question about governance structures, accountability and measures of effectiveness.n this paper, the authors conducted an international review of ten case studies from the United States, Canada, England, Belgium, New Zealand and Australia to explore several critical questions. Using qualitative data template, the research team reviewed plans, documents, web sites and published literature to address three questions. First, what are the governance arrangements for delivering regional planning? Second, what are the mechanisms linking regional plans with state plans (when relevant) and local plans? Third, what means and mechanisms do these regional plans use to evaluate and measure effectiveness? The case study analysis revealed several common themes. First, there is an increasing focus on goverance at the regional level, which is being driven by a range of trends, including regional spatial development initiatives in Europe, regional transportation issues in the US, and the growth of metropolitan regions generally. However, there is considerable variation in how regional governance arrangements are being played out. Similarly, there is a range of processes being used at the regional level to guide planning that range from broad ranging (thick) processes to narrow and limited (thin) approaches. Finally, evaluation and monitoring of regional planning efforts are compiling data on inputs, processes, outputs and outcomes. Although there is increased attention being paid to indicators and monitoring, most of it falls into outcome evaluations such as Agenda 21 or sustainability reporting. Based on our review we suggest there is a need for increased attention on input, process and output indicators and clearer linkages of these indicators in monitoring and evaluation frameworks. The focus on outcome indicators, such as sustainability indicators, creates feedback systems that are too long-term and remote for effective monitoring and feedback. Although we found some examples of where these kinds of monitoring frameworks are linked into a system of governance, there is a need for clearer conceptual development for both theory and practice.

Attitudes towards American brands and brand America

A study of 556 students at colleges and universities in Australia, Hong Kong and Singapore explored the relationship between attitude towards the United States and brand attitudes and preferences. Singaporean student attitudes towards both the US Government and US people were higher than were those of the Australian and Hong Kong students. Coke, Nike and McDonald's were among both the most-liked and disliked US brands among the international students, a finding suggesting that brands may possess both a 'lovemark' status, as described in the literature, and its opposite — 'loathemark' status — within the same demographic group. US brand preference scores did not offer support for the belief that international consumers 'vote with their pocketbooks' by refusing to purchase US brands if they have a negative attitude towards the United States. Among Hong Kong and Singaporean students, favourable attitudes towards the purchase of US brands was found to be positively related to favourability towards the US Government.

The Euro-American psyche and the imaging of Samoa in the early 20th century

Drawing on English language sources and material from Western Samoa (now Samoa), this examination of photographically illustrated serial encyclopaedia and magazines proposes an alternative historical analysis of the colonial photographs of Samoa, the most extensively covered field in Oceanic photographic studies. Photographs published between the 1890s and World War II were not necessarily from that era, and despite claims in the text of illustrated publications of an unchanged, enduring, archaic tradition in Samoa, the amazing variety of content and subject matter often offered contradictory evidence, depicting a modern, adaptive and progressive Samoa. Contrary to orthodox historical analysis, the images of Samoa in illustrated magazines and encyclopaedia were not limited to a small, repetitive gallery of partially clothed women and costumed chiefs.

Investment decision-making under risk (reliability) and uncertainty for infrastructure asset management

Risks and uncertainties are inevitable in engineering projects and infrastructure investments. Decisions about investment in infrastructure such as for maintenance, rehabilitation and construction works can pose risks, and may generate significant impacts on social, cultural, environmental and other related issues. This report presents the results of a literature review of current practice in identifying, quantifying and managing risks and predicting impacts as part of the planning and assessment process for infrastructure investment proposals. In assessing proposals for investment in infrastructure, it is necessary to consider social, cultural and environmental risks and impacts to the overall community, as well as financial risks to the investor. The report defines and explains the concept of risk and uncertainty, and describes the three main methodology approaches to the analysis of risk and uncertainty in investment planning for infrastructure, viz examining a range of scenarios or options, sensitivity analysis, and a statistical probability approach, listed here in order of increasing merit and complexity. Forecasts of costs, benefits and community impacts of infrastructure are recognised as central aspects of developing and assessing investment proposals. Increasingly complex modelling techniques are being used for investment evaluation. The literature review identified forecasting errors as the major cause of risk. The report contains a summary of the broad nature of decision-making tools used by governments and other organisations in Australia, New Zealand, Europe and North America, and shows their overall approach to risk assessment in assessing public infrastructure proposals. While there are established techniques to quantify financial and economic risks, quantification is far less developed for political, social and environmental risks and impacts. The report contains a summary of the broad nature of decision-making tools used by governments and other organisations in Australia, New Zealand, Europe and North America, and shows their overall approach to risk assessment in assessing public infrastructure proposals. While there are established techniques to quantify financial and economic risks, quantification is far less developed for political, social and environmental risks and impacts. For risks that cannot be readily quantified, assessment techniques commonly include classification or rating systems for likelihood and consequence. The report outlines the system used by the Australian Defence Organisation and in the Australian Standard on risk management. After each risk is identified and quantified or rated, consideration can be given to reducing the risk, and managing any remaining risk as part of the scope of the project. The literature review identified use of risk mapping techniques by a North American chemical company and by the Australian Defence Organisation. This literature review has enabled a risk assessment strategy to be developed, and will underpin an examination of the feasibility of developing a risk assessment capability using a probability approach.

Developing within-company information and communication technologies (ICT) innovation diffusion networks : a study of three Australian major contractors

The innovation diffusion and knowledge management literature strongly supports the importance of communities of practice (COP) for enabling knowledge about how to use and adopt innovation initiatives. One of the most powerful tools for innovation diffusion is word-of-mouth wisdom from committed individuals who mentor and support each other. Close proximity for face-to-face interaction is highly effective, however, many organisations are geographically dispersed with projects being virtual linked sub-organisations using ICT to communicate. ICT has also introduced a useful facilitating technology for developing knowledge networks. This paper presents findings from a research program concentrating on ICT innovation diffusion in the Australian construction industry. One way in which ICT diffusion is taking place was found to be through within-company communities of practice. We undertook in-depth unstructured interviews with three of the major 10 to 15 contractors in Australia to discuss their ICT diffusion strategies. We discovered that in all three cases,within company networked communities of practice was a central strategy. Further, effective diffusion of ICT groupware tools can be critical in developing COP where they are geographically dispersed.

How do retailers from emerging markets internationalize? : The case of Chilean retailers

This paper explores how retail firms from emerging markets internationalize and compete with multinational retailers from developed markets. Drawing on interviews with company managers, industry data and corporate reports, this paper provides insights into the successful internationalization process of two Chilean retailers in the Latin American region.