'Underdevelopment' and cheap labour supplies in Southern Rhodesia, 1923-1953

African Studies Seminar series. Paper presented July 1977Any study which seeks to explore the causes of ‘underdevelopment’ in a colonial or ex-colonial territory, is bound to be confronted with the challenge of deciding where capitalism stands in relation to the problem. Stated in unambiguous terms, the basic issue which analysts have been trying to resolve is whether capitalism is fundamentally beneficial or harmful to a developing country.... If we are going to prove, therefore, that capitalism causes underdevelopment, we would need to look at the manner in which modes of production – capitalist and pre-capitalist - interact with one another; how the capitalist mode penetrates into the pre-capitalist mode to form horizontal ties and alliances which maintain the exploitative structure as a whole; and how production in the pre-capitalist is geared and channelled to the advantage of the capitalist...

The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland

© 2019 Keyter, Salek, Banoo and Walker.Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move toward achieving their regulatory goals and stakeholders’ demands. The aims of this study were to compare the registration process and the regulatory review model of the South African Medicines Control Council (MCC) to that of four other similar-sized regulatory authorities and to identify areas for improvement that may inform recommendations to the South African Health Products Regulatory Authority (SAHPRA) as it looks to re-engineer and enhance the registration process in South Africa. Methods: A questionnaire describing the organisational structure, the registration process, good review and decision-making practices of the MCC was completed by the author (AK) for the purpose of this study and validated by the Registrar of the MCC. Similar questionnaires were also completed and validated by Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, Singapore’s Health Science Authority (HSA) and Switzerland’s Swissmedic. Results: A comparison of the MCC regulatory process with the four comparative agencies indicated that they all have similar requirements and employ a full-review model although the timelines for the MCC were considerably longer. However, similar quality measures were implemented by all authorities as part of their good review practices (GRevP) including prioritising transparency, communication, continuous improvement initiatives and training. Conclusion: Comparisons made through this study provided insight into the areas of the MCC registration process that may be improved and have informed recommendations to SAHPRA including the implementation of facilitated regulatory pathways, definition of targets for key milestones in regulatory review and formal implementation and monitoring of GRevP. In order to build quality into the review process the application of a standardised template for the clinical assessment of medicines such as the Universal Methodology for Benefit-Risk Assessment (UMBRA) could be considered as well as enhancing transparency and communication through the application of an electronic management system and the development of publicly available summaries for the basis of approval.Peer reviewedFinal Published versio

An Evaluation of the Regulatory Environment in South Africa: Improving the Review Process and Patients' Access to Medicines

National regulatory authorities (NRAs) are responsible for the evaluation of medicines and for ensuring that only those products which meet the requirements of quality, safety and efficacy are registered and made available to patients. The NRAs are required to effect such regulatory mandates efficiently and ensure timely patients’ access to medicines. Many NRAs, especially in resource-limited settings or emerging markets face challenges in fulfilling these mandates as resources are stretched to capacity. Adopting a risk-based approach to medicine evaluation can provide relief for NRAs striving towards improved regulatory performance. The NRAs may implement facilitated regulatory pathways, appropriate frameworks for benefit-risk (BR) assessment and abridged review processes in order to leverage reliance mechanisms and good regulatory practices to improve regulatory efficiencies. The aim of this research was to evaluate the regulatory environment in South Africa with a view to improve the review process for medicines and to ensure their timely access by patients. This was achieved through a review of the legislative framework and historical context supporting the new regulatory environment in South Africa and the transition from the Medicines Control Council (MCC) to South African Health Products Regulatory Authority (SAHPRA). The regulatory performance of the South African regulatory authority and how it compared to that of other agencies was evaluated and the strategies supporting enhanced BR assessment and reliance mechanisms were appraised. Various methodologies were considered in determining an appropriate study design and a mixed method approach, including a combination of self-administered questionnaires, focus groups and a case study, was adopted to support achieving the study objectives. A questionnaire was used to evaluate the review process of the MCC and the results demonstrated that the MCC was not able to meet target timelines for the review of new active substances (NASs). A comparison was made between the MCC and other similar NRAs using the same questionnaire. The results indicated that the MCC had similar requirements to other agencies and all the NRAs conducted a full assessment of applications for the registration of NASs. However, the approval times for the MCC were considerably longer. Further investigation into these lengthy timelines resulted in the analysis of the performance metrics of the MCC between 2015-2017 and of SAHPRA in 2018. A case study approach and focus group were used to evaluate strategies for enhanced communication of BR assessments and a questionnaire and two focus groups were conducted to understand the implications of the application of an abridged review in the evaluation of NASs. The results of these studies culminated in the development of a proposed improved model for the regulatory review process of new active substance (NASs) for SAHPRA. This programme of research has presented, in a seminal piece of work, key recommendations for the improvement of the regulatory review process as it may be applied by SAHPRA. The results from this work provide, for the first time, a baseline against which future improvements, implemented by SAHPRA, may be measured. The implementation of these recommendations will contribute towards an enhanced regulatory performance, underpinned by good regulatory, good review and good reliance practices. This will result in a stream-lined review process, improved regulatory responsiveness, consistency, transparency and accountability and ultimately patients’ timely access to medicines.

The South African Regulatory System: Past, Present, and Future

The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date failed and resources have been stretched to capacity resulting in the development of a significant backlog and extended timelines for product registration. The promulgation of the recently amended Medicines and Related Substance Act of 1965 triggered the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the Medicines Control Council (MCC). The aim of this review is to provide the historical context supporting the new regulatory environment in South Africa and the transition from the MCC to SAHPRA. Key recommendations to SAHPRA to ensure the full potential of the new regulatory environment in South Africa include: establishing a quality management system to safeguard accountability, consistency and transparency and to streamline the implementation of good review practices including quality decisionmaking practices and benefit-risk assessment; the measurement and monitoring of regulatory performance, targets for overall approval time and key review milestones to instill a culture of accurate metrics collection and measurement of key performance indicators and their continuous improvement and the employment of a risk-based approach to the evaluation of medical products and codify the use of facilitated regulatory pathways in policy and culture. The application of a risk-based approach to regulatory review commensurate with a product’s risk to patients will facilitate the application of increased resources for pharmacovigilance activities and to support the reliance and recognition of reference agencies.Peer reviewe

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulatory review processes and the good review practices that have been implemented by SAHPRA to support the assessment of new chemical entities and generic product applications for market authorization in the business-as-usual and backlog process streams. Methods: A questionnaire was completed and verified by SAHPRA to describe the structure of the organization, the resources available, the process for regulatory review of new chemical entities and generic products and the level of implementation of good review practices and regulatory decision-making practices for market authorization. Data were collected and analyzed on the overall approval timelines for new chemical entities and generic products registered by SAHPRA in 2020 in the business-as-usual and backlog process streams. Results: A full, independent scientific review was conducted for all new chemical entities and generic product applications in the business-as-usual stream. Facilitated regulatory pathways were introduced for the review of new chemical entities and generic products in the backlog stream. As a result, the timelines for approval of applications in the backlog stream were 68% quicker for both new chemical entities and generics, using facilitated regulatory pathways, such as abridged and verification review models. Conclusion: The comparisons made through this study provided insight into the improvements that have been made through the establishment of SAHPRA and the transition in 2018 from the MCC. The re-engineered processes that have been developed and implemented by SAHPRA to address the backlog in the review of the applications for market authorization have demonstrated a decrease in the overall median approval times. The expansion of these processes into the routine review of medical products will contribute to the enhanced regulatory performance of SAHPRA and patients’ access to new medicines.Peer reviewe

n Ondersoek na die sosiale ondersteuning van 'n groep meisies aan 'n kindersorgskool

Tesis (M.A.) -- Universiteit van Stellenbosch.Een kopie mikrofiche.Full text to be digitised and attached to bibliographic record

Validity of Symptom Reporting Following Mild Traumatic Brain Injury

Objective: Recent evidence of persistent reporting of symptoms after mild Traumatic Brain Injury (mTBI) has come under question, with the suggestion that participants may be over-reporting symptoms more generally. This study set out to determine the proportion of people reporting atypical symptoms and to explore the relationship between acute (1 month) atypical symptom reporting and perceptions of recovery and experience of typical symptoms following mTBI. Methodology: Data was drawn from the longitudinal population-based Brain Injury Incidence and Outcomes New Zealand (NZ) in the Community (BIONIC) study that was conducted in the Hamilton and Waikato districts. Cases included patients who had experienced a traumatic brain injury between the 1 st March 2010 and 28th February 2011. Cases were identified from the ACC database, community healthcare services, such as general practitioners (GPs) and physiotherapists, hospital admissions and discharges, sports clubs, concussion clinics and self-referrals. Participants completed the Rivermead Post-Concussion Questionnaire (RPQ) assessment at one month (n = 261) and twelve months post-injury (n = 193), in addition to data on a series of distractor (atypical) symptoms. Typical symptoms generally relate to post-concussion symptoms, while atypical symptoms do not form part of a concussion clinical presentation. Characteristics of the sample were analysed and the proportion of participants reporting atypical and typical mTBI symptoms were explored at both timepoints. T-tests were used when data satisfied parametric assumptions; if not satisfied, the Chi square tests tested non-parametric equivalent statistics (for nominal/categorical variables). The significance level was set at p <0.05. A regression analysis determined whether increased atypical symptoms reported at one month predicted persistent symptoms and perceptions of recovery at twelve months. Results: Data was available for n = 261 participants at one month and n = 193 at twelve months. Atypical symptoms were reportedly experienced by 25% of participants at one month and 16% of participants at twelve months. Atypical symptom reporting was higher in females than males. Sex, ethnicity, atypical symptoms and typical symptoms at one month following mTBI were significantly predictive of the one-year outcome, explaining 46% in the variance in typical post-concussion symptoms and 31 % of the variation in perceptions of recovery. Conclusion: One in four people reported atypical symptoms in the acute phase (intense symptoms at one month) post-injury, which reduced over time (twelve months). However, the models did not explain all the variance in the outcome, and other factors are likely to influence outcomes from mTBI. Given links to symptom reporting and perceptions of recovery at twelve months post-injury, acute atypical symptom reporting could be a red flag to indicate those who may experience poorer long-term outcomes and require additional support to facilitate recovery

The application of regression analysis to forecast transaction volumes on ATM devices

D.Litt. et Phil.The Self Service Channel (SSC) of First National Bank does not have a consistent and scientific method whereby the potential of a site could be evaluated for the placement of ATM devices. Estimating the potential number of transactions that could be generated at any particular site will enable FNB to determine whether or not an ATM would be viable at that site. Subsequently, the problem, or reason why this study was conducted, could be formulated as follows: There exist no uniform, consistent and scientific method that can be applied to predict the potential number of transactions that could be generated at an ATM, at any potential site. Therefore, the primary objective of this study was to develop a transaction-forecasting model (in the form of a regression model) whereby the potential number of ATM transactions at any given site can be estimated. Secondly, it was essential that this model must be developed in such a way that it is practical and easy to apply in the working environment. Employees of FNB must be able to use the model as part of their daily workflow and therefore it had to be made as user-friendly as possible. As the basis of this study, the first chapters focus on the study of available literature regarding location analysis and site selection. Literature regarding ATM location analysis as such is extremely limited, and therefore literature regarding the location of retail facilities was used as the foundation of the study. As with ATMs, most retail facilities are dependent on high pedestrian and traffic volumes to increase their sales. Variables that relate to, or that could be an indicator of pedestrian or traffic volumes at a particular site, was used (where possible) as variables in this study. ATM sites can be classified according to the type of facility where it is located, e.g. shopping centres, garages, etc. Each of the site classifications that were identified in the study, is influenced by different variables, which means that a different combination of variables could be included or used for each site classification. This resulted in the development of separate regression models for each site classification, depending on the specific set of variables influencing ATM transaction volumes at that site classification. When the variables were selected, one of the criteria that had to be kept in mind was the availability of data. One of the objectives of the study was to provide a model that is relatively simple to apply in practice. Data that needs to be gathered for input into the model (independent variables) must be easy to obtain. Furthermore, to develop a regression model, the variables used in the regression analysis must be quantifiable. Certain of the variables already had values that could be used. An example of such a variable was the Gross Lettable Area (GLA). The GLA of a shopping centre is measured in m², and this figure was used to measure the correlation between GLA and transaction volumes at shopping centres. Other variables, more specifically accessibility, visibility, competitors in the vicinity and FNB ATMs in the vicinity were not easy to quantify, and methods had to be developed to quantify these. After identifying the criteria that was used to quantify the independent variables, a sample of ATM sites - for each site classification - were selected. For each of these sites the relevant data were then collected. Data were collected by means of site visits to each of the sites included in the sample, GIS databases and requests for information from petrol garage owners, shopping centre management and retail store owners where the ATMs in the sample are located. Multiple regression analysis was applied to the variables in each classification that proved to have the strongest influence on transactions at that particular site classification. Of the 14 site classifications, models could be developed for 5 classifications. These 5 classifications, however, which include shopping centres, business nodes, convenience stores, garages and industrial areas, accounts for over 90% of all the ATM locations at FNB. The other classifications were excluded due to a lack of sufficient information for regression purposes. These models provide a scientific approach to ATM placements. It will also improve the decision-making process in FNB’s Self Service Channel, and result into cost savings by preventing the installation of ATMs at unprofitable locations. This study has made a significant contribution to the banking industry and the field of urban geography in terms of new knowledge, models and methods that were developed. There are various factors that impact on the performance of ATM devices at different locations. However, it is important to keep in mind that any scientific/statistical model could be applied only with limited success in practice, as human behaviour - and anything depending on it - cannot be fully explained or predicted by statistical models. Therefore, when these models are applied, the discretion and experience of the person will always play a role in reaching a final decision. The models and methods that were developed in this thesis will be developed and refined further on a continual basis to increase its accuracy and prediction ability