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.

Conceptualising value creation for social change management

Australian and international governments are increasingly adopting social marketing as a social change management tool to deal with complex social problems. Government decision makers typically need to balance the use of business models and management theories whilst maintaining the integrity of government policy. In taking this approach, decision makers experience management tensions between a social mission to equitably deliver social services and the accountability and affordability of providing quality social and health services to citizens. This is a significant challenge as the nature of the ‘social product’ in government is often more service-oriented than goods-based. In this paper the authors examine value creation in government social marketing services. The contribution of this paper is a value creation process model, which considers the nature of governments to create social good. This is particularly important for governments where consumers still expect value and quality in the service delivered, despite that offering being ‘free’.

ePortfolio use by university students in Australia: Informing excellence in policy and practice

In mid 2007, the Australian Learning and Teaching Council (ALTC), formerly the Carrick Institute for Learning and Teaching in Higher Education, commissioned an intensive research project to examine the use of ePortfolios by university students in Australia. The project was awarded to a consortium of four universities: Queensland University of Technology as lead institution, The University of Melbourne, University of New England and University of Wollongong.---------- The overarching aim of the research project, which was given the working title of the Australian ePortfolio Project, was to examine the current levels of ePortfolio practice in Australian higher education. The principal project goals sought to provide an overview and analysis of the national and international ePortfolio contexts, document the types of ePortfolios used in Australian higher education, examine the relationship with the National Diploma Supplement project funded by the Federal government, identify any significant issues relating to ePortfolio implementation, and offer guidance about future opportunities for ePortfolio development. The research findings revealed that there was a high level of interest in the use of ePortfolios in the context of higher education, particularly in terms of the potential to help students become reflective learners who are conscious of their personal and professional strengths and weaknesses, as well as to make their existing and developing skills more explicit. There were some good examples of early adoption in different institutions, although this tended to be distributed across the sector. The greatest use of ePortfolios was recorded in coursework programs, rather than in research programs, with implementation generally reflecting subject-specific or program-based activity, as opposed to faculty- or university-wide activity. Accordingly, responsibility for implementation frequently rested with the individual teaching unit, although an alternative centralised model of coordination by ICT services, careers and employment or teaching and learning support was beginning to emerge. The project report concludes with a series of recommendations to guide the process, drawing on the need for open dialogue and effective collaboration between the stakeholders across the range of contexts: government policy, international technical standards, academic policy, and learning and teaching research and practice.

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.

Regulating IVF and pre-implantation tissue-typing for the creation of "saviour siblings" : a harm analysis

Scientific discoveries, developments in medicine and health issues are the constant focus of media attention and the principles surrounding the creation of so called ‘saviour siblings’ are of no exception. The development in the field of reproductive techniques has provided the ability to genetically analyse embryos created in the laboratory to enable parents to implant selected embryos to create a tissue-matched child who may be able to cure an existing sick child. The research undertaken in this thesis examines the regulatory frameworks overseeing the delivery of assisted reproductive technologies (ART) in Australia and the United Kingdom and considers how those frameworks impact on the accessibility of in vitro fertilisation (IVF) procedures for the creation of ‘saviour siblings’. In some jurisdictions, the accessibility of such techniques is limited by statutory requirements. The limitations and restrictions imposed by the state in relation to the technology are analysed in order to establish whether such restrictions are justified. The analysis is conducted on the basis of a harm framework. The framework seeks to establish whether those affected by the use of the technology (including the child who will be created) are harmed. In order to undertake such evaluation, the concept of harm is considered under the scope of John Stuart Mill’s liberal theory and the Harm Principle is used as a normative tool to judge whether the level of harm that may result, justifies state intervention or restriction with the reproductive decision-making of parents in this context. The harm analysis conducted in this thesis seeks to determine an appropriate regulatory response in relation to the use of pre-implantation tissue-typing for the creation of ‘saviour siblings’. The proposals outlined in the last part of this thesis seek to address the concern that harm may result from the practice of pre-implantation tissue-typing. The current regulatory frameworks in place are also analysed on the basis of the harm framework established in this thesis. The material referred to in this thesis reflects the law and policy in place in Australia and the UK at the time the thesis was submitted for examination (December 2009).

G4C2C : enabling citizen engagement at arms' length from government

The recognition that Web 2.0 applications and social media sites will strengthen and improve interaction between governments and citizens has resulted in a global push into new e-democracy or Government 2.0 spaces. These typically follow government-to-citizen (g2c) or citizen-to-citizen (c2c) models, but both these approaches are problematic: g2c is often concerned more with service delivery to citizens as clients, or exists to make a show of ‘listening to the public’ rather than to genuinely source citizen ideas for government policy, while c2c often takes place without direct government participation and therefore cannot ensure that the outcomes of citizen deliberations are accepted into the government policy-making process. Building on recent examples of Australian Government 2.0 initiatives, we suggest a new approach based on government support for citizen-to-citizen engagement, or g4c2c, as a workable compromise, and suggest that public service broadcasters should play a key role in facilitating this model of citizen engagement.

Occupational health nurses’ roles, credentials, and continuing education in Ontario, Canada

The role of the occupational health nurse is broad and includes health care provider, manager/coordinator, educator/advisor, and case manager and consultant, depending on the type of industry and the country in which the nurse practices. Regardless of the type of role, the occupational health nurse must participate in continuing nursing education (CNE) activities. This study describes the roles, credentials, and number of CNE activities undertaken by occupational health nurses working in Ontario, Canada. Using a non-experimental descriptive design, a questionnaire was mailed to all practicing occupational health nurses who are members (n = 900) of a local nursing association. Three hundred fifty-four questionnaires were returned. Nurses reported a variety of roles in the following categories: case management, health promotion, policy development, infection control/travel health, ergonomics, education, research, health and safety, direct care, consultation, disaster preparedness, and industrial hygiene. Sixty-five percent of nurses held an occupational health nurse credential, and 19% of nurses attended more than 100 hours of CNE annually. Occupational health nurses have multiple workplace roles. Many attend CNE activities and they often prepare for credentialing.

Parent decisions regarding paid work and care of the child

Australia has witnessed a continual increase in maternal employment over the past two decades, which has placed focus on child care- its effects on the child and on early childhood education and care policy and provision. The engagement of women in the paid workforce contributes to national economic development, and is recognised in government policy incentives such as cash subsidies and tax relief for child care fees. These incentives are targeted towards mothers, to encourage them to engage in paid work. Making a contribution to the family’s economy and to a mother’s economic self sufficiency are two key drivers for women’s engagement in satisfying paid work. Many women also seek to maintain a personal investment in the development of their career, simultaneously ensuring that the child is experiencing suitable care. Policies that support women’s choices for satisfying workforce engagement and care arrangements are prudent for ensuring productivity of the economy as well as for enhancing the wellbeing of parents and children (OECD, 2007). Policies that provide family friendly employment arrangements, paid parental leave, and child care support, directly affect maternal employment decisions. Availability of family friendly employment policies is viewed as one way to not only promote gender equity in employment opportunities but also support the wellbeing of children and families (OECD, 2007). Yet there are not comprehensive and coherent policies on work and family in Australia. Australia is due to implement its first paid parental leave scheme in January, 2011. At the time of the data collection of this research, June 2007 to December 2008, Australia had no statutory provision for paid parental leave. To date, most research has focused on the consequences of paid work and care decisions made by women. Far less is known about the processes of decision-making and reasons underlying women’s choices. Investigation of what is most salient for women as they make decisions regarding engagement in paid work, and care for their child is important in order to inform policy and practices related to parental leave, family friendly employment and care for the child. This prospective longitudinal research was of 124 Australian expectant first-time mothers who completed questionnaires in their third trimester of pregnancy, and again at six and twelve months postpartum. First-time expectant mothers' decisions regarding engaging in paid work and selecting care for their child represent those of a group who are invested in motherhood and have usually had direct experience of engaging in paid work. They therefore provide an important insight into society’s idealised views about motherhood and the emotional and social uncertainty of making personal decisions where the consequences of such decisions are unknown. These decisions reflect public beliefs about the role of women in contributing to the country’s productivity and decisions about providing for the economic and emotional care needs of their family. As so little is known about the reasoning and processes of decision-making of women’s choices regarding paid work and care of the child this research was designed to capture expectant first-time mother’s preferred options for engaging in paid work and the care of their child, and investigate their actual decisions made at six and 12 months postpartum. To capture preferred options, decisions and outcomes of decisions regarding paid work and care of the child a prospective longitudinal research design was utilised. This design had three important components that addressed key limitations in the extant literature. First the research commenced in pregnancy in order to investigate preferences and beliefs about paid work and care and to examine baseline data that may influence decisions made as the women returned to paid work. Second the research involved longitudinal tracking from the antenatal time point to six and 12 months postpartum in order to identify the influences on decisions made. Third the research measured outcomes of the decisions made at each time point. This research examined the intentions, preferences, beliefs, influences, and outcomes of the decisions about engagement in paid work and choice of care. The analyses examined factors predicting return to paid work, the timing of return and extent of engagement in paid work; the care for the child; satisfaction with paid work; satisfaction with care for the child, motherhood and fulfilment; and maternal wellbeing at six and 12 months postpartum. The factors of interest were both rational/economic (availability and extent of paid and unpaid maternity leave; flexible work patterns) and emotional/affective (career satisfaction, investment in motherhood, and concern with quality of care for the child). Results indicated a group preference, and realisation for, return to paid work within the first year after the birth of a child but with reduction in hours to part-time. Most women saw paid work not only as a source of income but also as source of personal satisfaction. There were four key themes arising from this research. First, the women strived to feel emotionally secure when deciding about engaging in paid work and care of the child. To achieve emotional security women made their decisions for paid work and care of the child differently. A woman’s decision for maternal employment is a function of her personal beliefs, preferences and context regarding paid work and care of the child. She adjusts her established work identity with her new identity as a mother. The second key theme from this research is that the women made their decisions for maternal employment in response to their personal context and there were different levels of opportunities between the women’s choices. There is inequity of entitlement regarding work conditions associated with a woman’s education level. This has implications for the woman’s engagement in paid work, and her child’s health and wellbeing. The third key theme is that the quality of the child’s care mattered to the women in the research. They preferred care provided by parents and/or relatives more than any other types of care. The fourth key theme identified that satisfaction and wellbeing outcomes experienced as a result of maternal employment decisions were a complex interaction between multiple factors that change across time with the ongoing development of the mother’s identity, and the development of the child. The implications for policy within Australia are that the employment of mothers in the workforce necessitates that non-parental care becomes a public concern, where there is universal access to good quality affordable care for every child, not just for those who can afford it. This is equitable and represents real choice while supporting the rights of the child (Thorpe, Cloney & Tayler, 2010), protecting and promoting the public interest (Cleveland & Krashinsky, 2010). Children’s health and wellbeing will be supported (Moore & Oberklaid, 2010) while children are in non-parental care, and they will be exposed to environments and experiences that support their learning and development. The significant design of the research enabled the trajectories of first-time expectant women to be tracked from the antenatal point to 12 months postpartum. But there were limitations: the small sample size, the over-representation of the sample being highly educated and the nature of a longitudinal research that is set within the economic, social and political context at that time. These limitations are discussed in relation to suggestions for future research.

A social marketing approach to value creation in a Well-Women’s health service

Understanding consumer value is imperative in health care as the receipt of value drives the demand for health care services. While there is increasing research into health-care that adopts an economic approach to value, this paper investigates a non-financial exchange context and uses an experiential approach to value, guided by a social marketing approach to behaviour change. An experiential approach is deemed more appropriate for government health-care services that are free and for preventative rather than treatment purposes. Thus instead of using an illness-paradigm to view health services outcomes, we adopt a wellness paradigm. Using qualitative data gathered during 25 depth interviews the authors demonstrate how social marketing thinking has guided the identification of six themes that represent four dimensions of value (functional, emotional, social and altruistic) evident during the health care consumption process of a free government service.

A bureaucratic cinema: the fraught relationship between government and film

The interventions by the government in the production and circulation of film in late 1960s transformed the Australian cinema industry into a bureaucratic cinema because of its established agencies and institutions for the benefit of filmmakers. Training options expanded by the commencement of the Australian Film and Television School and the Film, Radio and Television Board of the Australia Council, which ran compulsory orientation seminars and workshops on the use of new equipments, helped the aspiring filmmakers to access money from the council's Basic Production Fund.

Queensland Government Agency Libraries Review: Options Paper

The Queensland Government Agency Libraries Review was undertaken during the period January-June 2010. The research project was sponsored jointly by the Director-General, Department of the Premier and Cabinet, and the Director-General, Department of Public Works. The objective of the project was to examine future options for the Queensland Government library and research services that provide clients with efficient and cost-effective access to the information they need to conduct government business, to develop a picture of the services provided, the information resources managed, the client base and staffing. The review also considered the environmental factors impacting on contemporary government libraries to determine possible strategies that would ensure a strong and sustainable future for the services. The review process culminated in identifying potential options for future service delivery. The preferred option involves a proposal for the centralizing responsibility for the coordination of a network of Queensland Government Libraries and Research Centres (QGLR). The establishment of a network of research centres, with a central point for coordination of common strategies, systems and processes will enable library and research services to flow around individual agencies, and provide clearer avenues for multi-disciplinary work that characterises contemporary government policy and government services. The key elements of the proposal include the development of a single library and research portal for all government officers, which can be tailored to meet their particular research needs; increasing the visibility and accessibility of information and knowledge resources to those officers regardless of their agency affiliation; introducing better, more cost effective purchasing and licensing arrangements; and the potential to have a voice of influence in the strategic agenda for the government’s use of information and research.

g4c2c: A model for citizen engagement at arms' length from government

The recognition that Web 2.0 applications and social media sites will strengthen and improve interaction between governments and citizens has resulted in a global push into new e-democracy or Government 2.0 spaces. These typically follow government-to-citizen (g2c) or citizen-to-citizen (c2c) models, but both these approaches are problematic: g2c is often concerned more with service delivery to citizens as clients, or exists to make a show of ‘listening to the public’ rather than to genuinely source citizen ideas for government policy, while c2c often takes place without direct government participation and therefore cannot ensure that the outcomes of citizen deliberations are accepted into the government policy-making process. Building on recent examples of Australian Government 2.0 initiatives, we suggest a new approach based on government support for citizen-to-citizen engagement, or g4c2c, as a workable compromise, and suggest that public service broadcasters should play a key role in facilitating this model of citizen engagement.

Educational and occupational outcomes amongst African men from refugee backgrounds living in urban and regional Southeast Queensland

Over the last ten years, approximately one third of refugee and humanitarian entrants to Australia have been adult men. To date, little research has been done on their health and settlement issues. Many of these men have come from the African continent. This paper reports on the educational and employment outcomes of a group of 173 recently arrived adult African men from refugee backgrounds who have settled in Southeast Queensland. Given the current government policy focus on regional resettlement, the paper compares key outcomes between the adult African men who settled in metropolitan Brisbane with those living in the Toowoomba-Gatton region. The study uses a peer interviewer model and a mixed method approach. Overall, we have found that African men who have settled in regional areas face significantly greater educational and occupational challenges than those who settled in the urban area. They report more negative experiences at educational institutions, are more likely to take jobs that are below their level of skills and qualifications, are more dissatisfied with their jobs, and report greater discrimination and difficulties while trying to secure adequate employment in Australia. A number of policy implications are discussed.

Psychological wellbeing of refugees resettling in Australia : a literature review prepared for the Australian Psychological Society

This literature review was developed as background for the formulation of an Australian Psychological Society position on the mental health and wellbeing of refugees resettling in Australia. The major aim is to provide a broad overview of the concerns related to refugee mental health and wellbeing within the Australian context. To begin, a brief overview of the definition of a refugee and the scope of refugee movement is provided. Next, the review examines the pre-displacement, post-displacement, systemic and socio-political factors that influence the process of adaptation in refugee resettlement. It then reviews documented approaches to psychological assessment and therapeutic interventions with refugees; and finally it summarises suggestions for assessment and intervention in these practice contexts.