Business & Economics Collected Works - Research Publications

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    Trust and the regulation of pharmaceuticals: South Asia in a globalised world.
    Brhlikova, P ; Harper, I ; Jeffery, R ; Rawal, N ; Subedi, M ; Santhosh, M (Springer Science and Business Media LLC, 2011-04-29)
    BACKGROUND: Building appropriate levels of trust in pharmaceuticals is a painstaking and challenging task, involving participants from different spheres of life, including producers, distributors, retailers, prescribers, patients and the mass media. Increasingly, however, trust is not just a national matter, but involves cross-border flows of knowledge, threats and promises. METHODS: Data for this paper comes from the project 'Tracing Pharmaceuticals in South Asia', which used ethnographic fieldwork and qualitative interviews to compared the trajectories of three pharmaceuticals (Rifampicin, Oxytocin and Fluoxetine) from producer to patient in three sites (north India, West Bengal and Nepal) between 2005-08. RESULTS: We argue that issues of trust are crucial in reducing the likelihood of appropriate use of medicines. Unlike earlier discussions of trust, we suggest that trust contexts beyond the patient-practitioner relationship are important. We illustrate these arguments through three case studies: (i) a conflict over ethics in Nepal, involving a suggested revised ethical code for retailers, medical representatives, producers and prescribers; (ii) disputes over counterfeit, fake, substandard and spurious medicines, and quality standards in Indian generic companies, looking particularly at the role played by the US FDA; and (iii) the implications of lack of trust in the DOTS programmes in India and Nepal for the relationships among patients, government and the private sector. CONCLUSIONS: We conclude that the building of trust is a necessary but always vulnerable and contingent process. While it might be desirable to outline steps that can be taken to build trust, the range of conflicting interests in the pharmaceutical field make feasible solutions hard to implement.
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    Understanding Health Research Ethics in Nepal.
    Sharma, JR ; Khatri, R ; Harper, I (Wiley, 2016-12)
    Unlike other countries in South Asia, in Nepal research in the health sector has a relatively recent history. Most health research activities in the country are sponsored by international collaborative assemblages of aid agencies and universities. Data from Nepal Health Research Council shows that, officially, 1,212 health research activities have been carried out between 1991 and 2014. These range from addressing immediate health problems at the country level through operational research, to evaluations and programmatic interventions that are aimed at generating evidence, to more systematic research activities that inform global scientific and policy debates. Established in 1991, the Ethical Review Board of the Nepal Health Research Council (NHRC) is the central body that has the formal regulating authority of all the health research activities in country, granted through an act of parliament. Based on research conducted between 2010 and 2013, and a workshop on research ethics that the authors conducted in July 2012 in Nepal as a part of the on-going research, this article highlights the emerging regulatory and ethical fields in this low-income country that has witnessed these increased health research activities. Issues arising reflect this particular political economy of research (what constitutes health research, where resources come from, who defines the research agenda, culture of contract research, costs of review, developing Nepal's research capacity, through to the politics of publication of data/findings) and includes questions to emerging regulatory and ethical frameworks.
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    Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal.
    Brhlikova, P ; Harper, I ; Subedi, M ; Bhattarai, S ; Rawal, N ; Pollock, AM (Springer Science and Business Media LLC, 2015-06-14)
    BACKGROUND: Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance. RESULTS: Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes. CONCLUSIONS: In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential medicines from the only public producer while donor funded programmes rely on international manufacturers compliant with international GMP standards. We also found evidence of private hospitals bypassing national medicines approvals process. Policies in support of local pharmaceutical production in developing countries as a source of essential medicines need to examine carefully how GMP regulations impact on regulators, local industry and production of essential medicines in practice.
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    Comment - WHO outsourcing dilemma: for whose benefit, at whose expense?
    Sharma, JR ; Harper, I ; Adhikari, R ; Smith, P ; Thapa, D ; Chand, OB ; Malata, A (BMJ, 2016)
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    Academy of Management Journal, 1958-2014: a citation analysis
    Calma, A ; Davies, M (SPRINGER, 2016-08)
    This paper provides a citation network analysis of publications from the Academy of Management Journal, one of the key US-based journals in the field of Management. Our analysis covers all publications in the journal from 1958–2014. This represents the entire history of the journal until the arbitrary cut-off point of our study. The paper analyses the most published authors, most cited articles, most cited authors, top institutions, and the nationalities of authors that are most represented in the journal. 2304 articles containing 114,550 references were taken from the primary data source, the Web of Science™. An analysis of 114,550 citations was carried out using the Web of Science™ online analytics tool and Excel®. Gephi™, a data visualisation and manipulation software, was used to provide a visual representation of the citation networks. Results indicate that the most published authors within AMJ throughout the journal’s history are Ivancevich, Golembiewski and Hambrick. The three most cited authors within AMJ are Pfeffer, Porter and Thompson. The single most cited article is Pfeffer and Salancik’s 1978 article The external control of organizations: a resource dependence perspective. A keyword analysis revealed that the most important terms used in the journal’s history were ‘Performance’, ‘Organization’ and ‘Work’. Results from this paper extend our previous citation analyses of key journals in the discipline of Higher Education to a new discipline—the field of Management. The paper provides evidence of how visual analyses can help to represent the citation “geography” of a journal over time.
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    APOE and BDNF polymorphisms moderate amyloid β-related cognitive decline in preclinical Alzheimer's disease
    Lim, YY ; Villemagne, VL ; Laws, SM ; Pietrzak, RH ; Snyder, PJ ; Ames, D ; Ellis, KA ; Harrington, K ; Rembach, A ; Martins, RN ; Rowe, CC ; Masters, CL ; Maruff, P (NATURE PUBLISHING GROUP, 2015-11)
    Accumulation of β-amyloid (Aβ) in the brain is associated with memory decline in healthy individuals as a prelude to Alzheimer's disease (AD). Genetic factors may moderate this decline. We examined the role of apolipoprotein E (ɛ4 carrier[ɛ4(+)], ɛ4 non-carrier[ɛ4(-)]) and brain-derived neurotrophic factor (BDNF(Val/Val), BDNF(Met)) in the extent to which they moderate Aβ-related memory decline. Healthy adults (n=333, Mage=70 years) enrolled in the Australian Imaging, Biomarkers and Lifestyle study underwent Aβ neuroimaging. Neuropsychological assessments were conducted at baseline, 18-, 36- and 54-month follow-ups. Aβ positron emission tomography neuroimaging was used to classify participants as Aβ(-) or Aβ(+). Relative to Aβ(-)ɛ4(-), Aβ(+)ɛ4(+) individuals showed significantly faster rates of cognitive decline over 54 months across all domains (d=0.40-1.22), while Aβ(+)ɛ4(-) individuals showed significantly faster decline only on verbal episodic memory (EM). There were no differences in rates of cognitive change between Aβ(-)ɛ4(-) and Aβ(-)ɛ4(+) groups. Among Aβ(+) individuals, ɛ4(+)/BDNF(Met) participants showed a significantly faster rate of decline on verbal and visual EM, and language over 54 months compared with ɛ4(-)/BDNF(Val/Val) participants (d=0.90-1.02). At least two genetic loci affect the rate of Aβ-related cognitive decline. Aβ(+)ɛ4(+)/BDNF(Met) individuals can expect to show clinically significant memory impairment after 3 years, whereas Aβ(+)ɛ4(+)/BDNF(Val/Val) individuals can expect a similar degree of impairment after 10 years. Little decline over 54 months was observed in the Aβ(-) and Aβ(+) ɛ4(-) groups, irrespective of BDNF status. These data raise important prognostic issues in managing preclinical AD, and should be considered in designing secondary preventative clinical trials.
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    Africa, and China’s One Belt, One Road initiative: Why now and what next?
    JOHNSTON, L (International Centre for Trade and Sustainable Development, 2016)
    China’s growing outbound investment ambitions could be as transformative for today’s poor countries as inbound investment was for China. This will depend upon how recipient developing economies, in particular in Africa, utilise China’s investor interest for their own sustainable development.
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    Leading from the Frontline: Developing Leader Identity and Leadership Self-Efficacy among Frontline Managers.
    OLSEN, J ; Butar, I ; Gahan, P (Centre for Workplace Leadership, The University of Melbourne, 2016)
    Frontline managers are responsible for the supervision of non-managerial employees and overseeing day-to-day operations in general. They are often directly involved in employee recruitment, training, and performance management and are critical to implementing practices and innovations that enhance productivity (Ahmed, Shields, White, & Wilbert, 2010; Brewer, 2005; Kraut, Pedigo, McKenna, & Dunnette, 1989; Purcell & Hutchinson, 2007; Risher, 2010). Frontline managers in the service industry are no exception, and should receive more attention as the service industry expands. We therefore designed a research study based in a large organisation in the food service industry. Through this study, we sought to understand what factors relate to the important concepts of leader identity and leadership self-efficacy at the frontline. We first provide some background on these concepts, as well as a number of potential determinants. We then describe the methodology of our study, followed by the findings and their implications.
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    Workplace Gender Equality Strategy Project - Final Report
    Olsen, J ; Orpin, S ; Good, L ; TOWNS, D (Centre for Workplace Leadership, University of Melbourne, 2015)
    Progress towards workplace gender equality is a national priority. For Australian organisations, closing the gender gap and maximising the potential of both male and female employees is crucial for increasing productivity and securing future growth. The Workplace Gender Equality Agency’s (WGEA’s; 2014) gender equality indicators have found that while 45% of Australian employers have policies on flexible work, and family and caring responsibilities, only about 13% have a strategy for implementing such policies. Over half of organisations have a standalone gender equality policy, but only 7% have a gender equality strategy. Women’s representation is low at management levels, with women comprising around 26% of the top three layers of the management hierarchy in Australian organisations with 100 or more employees. Pursuit of flexible work practices and promotion of gender equity needs to be implemented in a more strategic, integrated and sustainable way in order to have real effect at the workplace level.