4. Electronic Theses and Dissertations (ETDs) - Faculties submissions

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    Challenges of Entering New Pharmaceutical Markets in Nigeria and Ghana
    (University of the Witwatersrand, Johannesburg, 2024) Motshoane, Thato Sebabatso
    Background: The pharmaceutical market is renowned for its stringent regulations and continuous production of superior drugs and products intended for human consumption. This study investigates the regulatory landscape of two African countries, namely Nigeria and Ghana, and the challenges of entering these economies as a result of the absence of regulatory harmonisation. The goal is to establish a regulatory framework that will facilitate the introduction of novel medicines and medical supplies into the market. Method: The research methodology employed involved the collection, processing, and evaluation of empirical evidence. The chosen strategy was qualitative research. Results: Entering new or foreign pharmaceutical market requires careful consideration, planning, and abiding by the regulatory requirements of the respective countries. Sustained prosperity will be guaranteed by enhancements in quality control and partnerships with local distributors and manufacturers. Partnering with local consultants who are familiar with the regulatory landscape, as well as local laws and policies is crucial. Lastly, it is important to be familiar with regulatory requirements from NAFDAC and the FDA to ensure ongoing compliance with evolving regulations. Conclusion: Improving the local pharmaceutical market in both countries encourages the entry of foreign international pharmaceutical corporations, thus stimulating the economy of both nations. Local pharmaceutical companies in Ghana and Nigeria can strengthen their competitive edge by increasing barriers to entry. This can be achieved by raising the calibre of goods produced, increasing operational effectiveness, lowering production costs, and engaging in local innovation initiatives. Locals should maximize local government subsidies while utilizing the local context, including the nation's culture and consumer base to their advantage
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    Development of a Commercial Manufacturing Process of 9-[(R)-2- (phosphonomethoxy)propyl] adenine (PMPA): A Key Intermediate for the Production of Tenofovir-based HIV Medicines
    (University of the Witwatersrand, Johannesburg, 2023) Mbutho, Banele; Gohain, Mukut; De Koning, Charles
    South Africa runs the largest antiretroviral (ARV) program in the world and yet 99% of the active pharmaceutical ingredients (APIs) used to make ARVs are imported from China. Dependence on imported APIs has major cost implications and influences the medication’s security of supply. This project was concerned with making it possible to produce the APIs tenofovir, a precursor for tenofovir disoproxil fumarate and tenofovir alafenamide locally and at a lower cost. A new synthetic route recently introduced by Medicines 4 All (M4ALL) was studied and used in this dissertation. The four-step process that produces an adenine derivative was optimized and scaled into a commercial industrial process producing tenofovir intermediates in repeatable yield and purity. This route was determined to be the most cost-effective since it utilized low cost and commercially available diaminomaleonitrile and triethyl orthoformate as starting materials—contrary to the synthetic routes currently used by the 17 largest tenofovir manufacturers. Key process improvements included a decrease in the number of solvents used and the minimization of by-product formation. Results showed that high yields of tenofovir intermediates were successfully synthesized using this new route. As such, the chemical company we conducted this research in, Chemical Process Technology Pharma will be able to employ this synthetic methodology to affordably produce the APIs used in the manufacturing of ARVs locally improving access to affordable medication.
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    Anti-competitive behaviour as a ground for compulsory licensing of pharmaceutical patents in South Africa
    (University of the Witwatersrand, Johannesburg, 2023-09-14) Omar, Fathima; Andanda, Pamela
    While the South African Patents Act provides for compulsory licensing in instances of an abuse of patent rights, millions of South Africans remain unable to access essential medicines because of inter alia the high prices charged by pharmaceutical patent holders. This research explores the idea of utilising Article 31(k) of the TRIPS agreement – which allows for compulsory licences to be issued to remedy anti-competitive behaviour – to ensure access to patented essential medicines. The central argument in the report is that compulsory licenses on Article 31(k) grounds should be granted by the competition authorities after having found anti- competitive behaviour on the part of the pharmaceutical patent holder. Moreover, this research provides solutions and recommendations to appropriately deal with the role of the competition authorities in the regulation of patented pharmaceutical