Statement of the issue: Facing large HIV-infected populations, Sub-Saharan African countries are producing antiretroviral (ARV) drugs under provisions of the World Trade Organization’s Agreement on the Trade-Related Aspects of Intellectual Property (TRIPS). Article 7 states that the protection of intellectual property should increase technology transfer to developing countries. This clause and the debate over domestic manufacturers’ ability to provide low-cost ARVs need examination. Methods: Case studies from ARV manufacturing initiatives in Tanzania and South Africa analyzed conditions affecting two outcomes: the type of technology transfer arrangement entered (voluntary license or imitation) and the affordability of ARVs. Data were collected and analyzed from documents, key-informant interviews, and observation. Chi-squared and phi correlation statistics were then conducted across developing countries to test the association of voluntary ARV licensure with TRIPS-compliant patents and domestic firm ownership (state or private). Results: Tanzania’s weak patent system and poorly-financed, partially state-owned firm dissuaded industry investment, but attracted a non-government organization to transfer technology through imitation. Donor-financed ARV tenders, however, restrict competition to international quality-accredited products not produced by the firm. Without large volumes and manufacturing capacity, it cannot achieve economies of scale to reduce prices below imported ARVs. In South Africa, civil society challenged the strong patent system and poor government commitment that inhibited an ARV rollout. This and a well-financed, publicly-traded firm leveraged voluntary licenses. With international quality approval, the firm increased first-line ARV affordability; however, limited domestic competition keeps treatment prices above those of neighbouring countries. A multi-country analysis found 321 generic ARV manufacturing initiatives in 86 firms across 25 developing countries. Voluntary ARV licenses had a strong positive association with TRIPS-patent compliance (ф=.56, p<.0001) and a weak negative association with state-ownership (ф=.19, p<.0001). Firms in South Africa and India were granted 77% of licenses and accounted for most quality accredited generic ARVs. Conclusion: Despite positive association, technology transfer does not readily result from patent protection, particularly to state-owned firms. Developing countries must enact policies to enable affordable ARVs; yet, they must be cautious using local production to increase ARV access, as most initiatives cannot compete with high-volume generic manufacturers.

Statement of the issue: Facing large HIV-infected populations, Sub-Saharan African countries are producing antiretroviral (ARV) drugs under provisions of the World Trade Organization’s Agreement on the Trade-Related Aspects of Intellectual Property (TRIPS). Article 7 states that the protection of intellectual property should increase technology transfer to developing countries. This clause and the debate over domestic manufacturers’ ability to provide low-cost ARVs need examination. Methods: Case studies from ARV manufacturing initiatives in Tanzania and South Africa analyzed conditions affecting two outcomes: the type of technology transfer arrangement entered (voluntary license or imitation) and the affordability of ARVs. Data were collected and analyzed from documents, key-informant interviews, and observation. Chi-squared and phi correlation statistics were then conducted across developing countries to test the association of voluntary ARV licensure with TRIPS-compliant patents and domestic firm ownership (state or private). Results: Tanzania’s weak patent system and poorly-financed, partially state-owned firm dissuaded industry investment, but attracted a non-government organization to transfer technology through imitation. Donor-financed ARV tenders, however, restrict competition to international quality-accredited products not produced by the firm. Without large volumes and manufacturing capacity, it cannot achieve economies of scale to reduce prices below imported ARVs. In South Africa, civil society challenged the strong patent system and poor government commitment that inhibited an ARV rollout. This and a well-financed, publicly-traded firm leveraged voluntary licenses. With international quality approval, the firm increased first-line ARV affordability; however, limited domestic competition keeps treatment prices above those of neighbouring countries. A multi-country analysis found 321 generic ARV manufacturing initiatives in 86 firms across 25 developing countries. Voluntary ARV licenses had a strong positive association with TRIPS-patent compliance (ф=.56, p<.0001) and a weak negative association with state-ownership (ф=.19, p<.0001). Firms in South Africa and India were granted 77% of licenses and accounted for most quality accredited generic ARVs. Conclusion: Despite positive association, technology transfer does not readily result from patent protection, particularly to state-owned firms. Developing countries must enact policies to enable affordable ARVs; yet, they must be cautious using local production to increase ARV access, as most initiatives cannot compete with high-volume generic manufacturers.

Reports and consultative documents published at national level since about 1980 have indicated that British Industry must look to modern technology and also educate and train its workers on a 'broad base', with an 'integrated' approach. Traditionally, and still very much the mode of operation, teaching has been confined within subject boundaries. A research group was established by Professor Bajpai consisting of the author, Mr Rod Bond (Burleigh Community College, Loughborough) and a few others working overseas to investigate a teaching strategy based on an interrelated approach to teaching mathematics. Measurement was chosen as the first topic of investigation using this approach which then formed the basis for further research undertaken by the two research workers of the group whose work is reported in the form of two theses. This thesis aims to show that mathematics is naturally related to science and technology in industrial practice and that when taught in an interrelated way it would be more interesting and have more relevance to real applications in technology-based employment at craft and technician levels. To help establish the case experiments carried out by the author are referred to; these include a few case studies, a questionnaire survey and results analysed from more than five hundred basic mathematics tests. The various kinds of mathematics taught in further education are described and compared with mathematics in a practical context as seen from a case study within an engineering training school. Next a survey of mathematics at work shows that, like the training school, there is a task associated with the mathematics which is also related to science or technology or both. Another case study in the pharmaceutical industry lends further support to the way mathematics is used in industry. Much of the mathematics also seems to be basic and used in association with measurement and a particular task. It was decided by the research group that a tape/slide programme on measurement for students and educators should be developed by the author and tested in different situations. Teaching modules on relevant mathematical topics based on the interrelated approach were constructed for students with strong support from industry in the form of materials and advice. Testing of these modules, in their original and revised forms after feedback, is described. These trials were also carried out in other establishments. Modules based upon the interrelated approach developed by the author formed a basis for promoting the underlying philosophy behind this approach. These were presented to educators in in-service training and staff development programmes in the north western region of the UK with success. Observations and conclusions drawn clearly indicate that this type of method makes mathematics more interesting and relevant for students of different abilities and backgrounds. Finally pointers are given in the thesis as to the wider use and promotion of this approach for teaching mathematics in further education.

This study examines tools and practices involved in a large scale and multi-sited clinical trial of a potential drug against obesity. Two tools are in focus: a clinical research protocol and a computer control system. The analysis is based on there being different ways in which the tools are localized in order for the work to flow smoothly and to produce reliable data. It does this through delineating different types of work performed: production tasks, classical managerial work, compliance work and the work of coordinating beliefs and goals. The study is based on interviews, observations and documentary analysis. Through describing these types of work and how it is organized, the study emphasizes the trial as being part of an industrial production process. Hence, the tools are used not only to produce reliable data, but also to manage the work of the tools’ users in order to enable a smooth production process. In line with such a description, the protocol and computer control system are seen as objects that discipline practice, something that also resonates in the way staff talk about their work. The dissertation shows how the tools, despite this, leave room for aspects of clinical trial work that are both rational/technical and experiential/contingent. The dissertation also shows that obesity is enacted in different ways in the practices performed in the trial. Making sense of these somewhat contradictory enactments requires work referred to as coordination of beliefs about what obesity is, as well as of the different goals of the trial. By such a focus on invisible work, the dissertation shows that those nurses, dieticians and doctors involved in the everyday follow-through of the trial have a strategic position in mediating between pharmaceutical companies and their potential market for the drug under study, namely the trial participants.

The traditional quality culture in the pharmaceutical industry is driven by the regulatory process of marketing authorisation and manufacturing authorisation. These components of the South African regulatory control system are exclusively technically-orientated, with no managerial focus. This study identifies several quality management principles which could find general application in the pharmaceutical industry. The research compares the current regulatory control system with the total quality concept, and highlights the positive contribution which the total quality approach is able to make in terms of its field of reference; the strategic business value of quality; quality policy formulation; the quality organisational structure; enhanced operations management; and management's control over quality costs, in particular / Economic & Management Sciences / M.Com. (Business Economics)

The traditional quality culture in the pharmaceutical industry is driven by the regulatory process of marketing authorisation and manufacturing authorisation. These components of the South African regulatory control system are exclusively technically-orientated, with no managerial focus. This study identifies several quality management principles which could find general application in the pharmaceutical industry. The research compares the current regulatory control system with the total quality concept, and highlights the positive contribution which the total quality approach is able to make in terms of its field of reference; the strategic business value of quality; quality policy formulation; the quality organisational structure; enhanced operations management; and management's control over quality costs, in particular / Economic and Management Sciences / M.Com. (Business Economics)