'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

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

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.

Pathology of Surgically Resected Lung Cancers Following Neoadjuvant Therapy.

In around 30% of patients, non-small cell lung cancer is diagnosed at an advanced but resectable stage. Adding systemic therapy has shown clear benefit over surgery alone in locally advanced disease, and currently, chemo-immunotherapy in the adjuvant or neoadjuvant setting is the new standard for patients without targetable mutations. One major advantage of the neoadjuvant approach is the possibility of an immediate evaluation of the treatment effect, highlighting the role of pathology as an important contributor at the forefront of clinical decision-making and research. This review provides a summary and an update on current guidelines for histological evaluation of treatment effect after neoadjuvant therapy, also known as regression grading, and discusses newer data focusing on areas of evolving questions and controversies, such as the gross examination of the tumor and tumor bed, weighted versus unweighted evaluation approaches, discussion of histologic tumor type-specific cut-offs for major pathologic response, assessment of lymph nodes and regression grading after immunotherapy and targeted therapy. As no data or recommendations exist on regression grading of multiple tumor nodules, a practical approach is recommended. Lastly, we will touch on additional tissue biomarkers and summarize recent advances in the ardently discussed field of using circulating tumor DNA for the evaluation of treatment response

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

Reinventing service delivery in Namibia.

International Conference on Entrepreneurship and Innovation (5th : 2007 Oct. 24-25 : NUST)The main purpose of any public service globally, is to promote the general welfare of the citizens of that specific country. The assumption can therefore be made that in order to promote the welfare of the citizens; the public sector should be managed effectively, efficiently and economically. Therefore, if the public sector did not perform according to these principles, the public sector should reform itself to meet the needs and expectations of its citizens. Over the last few years we have seen significant changes taking place in public administration and management in transitional countries. The main factors leading to public sector reform can be traced back to the following criteria, namely, the redefinition of the role of the state within society and the emphasis of governments to adhere to the principles of good governance through increased transparency , openness, accountability and increasing citizen participation and the rooting out of corruption. The purpose of this article is to briefly explain what measures the Namibian government has undertaken to improve service delivery

Effectiveness and efficiency of a public-private partnership arrangement: A case study of perceptions on the Ward Contractor System in the City of Windhoek, Namibia.

This research project undertaken during sabbatical leave from the NUST.The item was published in 2010 as: Enhancing urban service delivery through partnerships in Namibia: Perceptions on a public-private partnership arrangement in Namibia / by Charles Keyter. Saarbrucken, Germany: LAP Lambert Publishing, 2010.Public private partnerships (PPP) have become an important instrument in sub-national government’s development assistance. PPP also adds a new variant to cooperation between governments and the economy of their countries. It concerns the establishment of purposeful joint business ventures at programme level, which aims at providing a more efficient and effective service delivery. Furthermore, the aim of PPP arrangements is to ensure that the approach being use is pro poor. In this regard the City of Windhoek has embarked on such a PPP arrangement to enhance the living conditions of the residents within the city, create an entrepreneurial spirit amongst small scale independent providers and to ensure that the most vulnerable groups within the Namibian society, women, benefit from this arrangement. The purpose of this project is to determine the effectiveness and efficiency of the ward contractor project based on the perceptions of the various stakeholders involved in the project. The ultimate aim is to investigate the link between the theory and the practice and that this specific project lives up to its goals and objectives. This project will generate knowledge that will be of benefit to decision makers, practionaries and scholars interested in PPP within the Namibian, regional and international context. The knowledge gain with this project will be disseminated at local, regional and international forums to enhance the subject field and practice of public-private partnership and entrepreneur ship

Particle size and metal composition of gouging and lancing fumes

MSc (Occupational Hygiene), North-West University, Potchefstroom Campus, 2017Background: Gouging (used for preparation of the weld groove) and lancing (severs or removes metal) processes during mining maintenance operations liberate fumes of unknown particle sizes and metal composition. These fumes are formed when vaporised materials condense in cool air. These processes give rise to very fine solid particles of sizes usually smaller than 1 μm in diameter which will generally agglomerate to form bigger clusters of particles. Inhalation of such a “metal fume mixture” may lead to adverse health effects. Gouging and lancing, specifically, liberate fumes of unknown particle sizes and metal composition, as most studies only focus on welding fumes. Aims and objectives: A field study was conducted to determine the particle size fractions as well as metal composition of fumes emitted during gouging and lancing processes. This study provided the necessary information to employers on what their workers are exposed to and therefore, how to prevent or control exposure to these fumes and this may improve occupational health and hygiene of workers utilising these gouging and lancing methods. The study also aimed to include metal fumes and particle fractions not previously included (such as nanoparticles) during respiratory exposure sampling. The determination of the particle size fractions and metal composition of the metal fume mixtures made it possible to determine the possible health effects associated with the inhalation thereof. Methods: Randomised side-by-side area samples were collected of metal cutting fumes liberated during gouging and lancing processes, respectively. These processes form part of maintenance work and was performed in three workshops at an open cast iron ore mine in South Africa. Samplers included the Institute of Occupational Medicine (IOM) sampler (inhalable fraction), a GK2.69 cyclone (thoracic fraction), an aluminium cyclone (respirable fraction), a Nanoparticle Respiratory Deposition (NRD) sampler (nano-size fraction) and an open-face filter cassette (particle size distribution). These samplers were mounted at a minimum height of 1.3 m and a maximum height of 1.7 m which is representative of the height of workers standing up by means of a randomised sampling station. Samples were collected 2 m from the source during gouging processes and at a range of between 5 and 10 m from the source during lancing processes. A total of 46 samples were collected during gouging processes (23 in the maintenance workshop and 23 in the mining contractor’s workshop) and 26 during lancing processes. Results: Particles in all fractions were present in the metal fumes emitted during gouging and lancing processes. Ambient workplace concentrations of the nano-sized fraction indicated a range of 1.01 – 3.40 mg/m3 in the workshops. A total of 26 metals were present in the various particle fraction sizes and included arsenic, chromium, cobalt, lead, manganese, mercury and nickel. Lead was mostly found during lancing whereas manganese and nickel were found in all of the workshops and fractions sampled. Lancing processes (x̄ = 32.3 nm) emit on average smaller particles than gouging processes (x̄ = 171.8 nm). The various fraction sizes did not statistically differ between gouging and lancing. Statistically significant differences were found between gouging and lancing for copper, iron, molybdenum and nickel emission, with copper, iron and nickel emission showing a higher concentration during gouging processes and molybdenum emission showing a higher concentration during lancing processes. In the nano-size fraction, the head nut liberated the highest mean ambient concentration level (2.46 mg/m3) and backhoe shovel 2 the lowest (1.74 mg/m3). Fumes emitted from backhoe shovel 1, the crusher liner and the axle liner contained the smallest particles with averages of 40.3 nm, 28.5 nm and 36.1 nm, respectively. Conclusions: Particle size fractions within the inhalable, thoracic, respirable as well as nano-size fractions were present in the metal fumes. Lancing could be considered more hazardous than gouging as mean particle sizes are smaller than particles emitted during gouging. Nanotoxicology is still an unfamiliar field and nanoparticles may cause detrimental health effects beyond the respiratory system. This indicates the necessity to include the nano-size fraction during future personal exposure assessments and monitoring in addition to inhalable and respirable sampling and may guide the mine to implement various control and safety measures, specifically for nanoparticles, to protect their workers’ healthMaster

Course development and practical sessions on the distance education mode. Paper presented at a workshop.

The paper addresses the topic of distance education in general and how practical sessions could be incorporated and implemented as part of a course on the distance education mode