Introduction: Due to the increase in healthcare costs, generic medicines have been adopted for used in both developed and developing countries. When a generic or ‘multisource interchangeable medicine’ is to be registered, studies that prove that the generic is equivalent to the Innovator Product (IP) are used. The generic medicine is required to prove that it will mirror the IP in terms of safety, quality and efficacy and, in South Africa, the Medicines Control Council (MCC) ensures that generic medicines meet these requirements. Generic medicines may be registered using bioequivalence data obtained from comparison with a domestic reference product (usually the local innovator product) or in certain cases, a foreign reference product (FRP). The bioequivalence data can either be from in vivo or in vitro studies. The MCC guidelines require that for modified release preparations, in vivo bioequivalence studies are done for approval of registration; the exception being if a proportionally higher dose has already been registered. No information is currently given to prescribers and dispensers or to the public about whether a generic product was registered against a foreign or domestic reference product. Aims and Objectives: 1.) To determine the number of generic medicines in a predetermined sample registered using a FRP as comparator and to document the transparency of pharmaceutical companies when approached to disclose information regarding the registration of these products. 2.) To describe and document the use of the Promotion of Access to Information Act (Act 2 of 2000) [PAIA] from the perspective of a ‘layperson’ in the context of medicines’ regulation, in both private and public bodies. Methods: 20 modified release and Biopharmaceutics Classification System (BCS) class IV products were selected from the ‘generics dictionary’ – a commercial publication – and letters were sent to the manufacturers of the products requesting information about the tests done to prove equivalence and whether they were performed against a domestic or foreign reference product. The same information was also requested from the MCC. The requests were all made using the Promotion of Access to Information Act (PAIA). Results: Nine companies were represented by the 20 products chosen. Information was obtained about thirteen products. Ten of these products were registered using FRPs. Four products were registered based only on comparative dissolution studies. Four companies provided the requested information, two companies responded by refusing the requests and three did not respond at all. The MCC refused the request for information even after an internal appeal was lodged. Conclusions: The Promotion of Access to information Act was unsuccessful in obtaining information from the public body, and partly successful in obtaining it from the private bodies. While the title of the Act seems to indicate that the Act can be used to obtain information as such, it only provides for access to specified records. The MCC and the pharmaceutical companies involved in the study were under no obligation to provide the information as the request had not complied with PAIA requirements. The use of FRPs for registration is a reality in the pharmaceutical industry in South Africa. Neither the public nor healthcare professionals who prescribe medicines or who are involved in dispensing generic medicines as substitutes are aware of whether or not a FRP has been used to register a generic. Interchangeability cannot necessarily be guaranteed if the reference product was not proven equivalent to the local innovator product. It is debatable as to whether or not this information would be of any particular benefit to members of the public. Prescribers may choose to write ‘no substitution’ on their prescriptions if they were unconvinced that an FRP is acceptable. This could have consequences for healthcare costs. Dispensers are the most vulnerable in South Africa as they are obliged by law to substitute generic medicines when innovator medicines have been prescribed. Dispensers’ views on the acceptability of the use of FRPs can be seen as irrelevant. In the end, as this study demonstrates, the only option in the present situation is to rely entirely on the MCC’s rigour in assessing applications for registration of generic medicines.

This study briefly discusses land restitution in several countries in Europe and the Americas, the history of land deprivation in South Africa, and the legislation introduced to remedy the inequality of land ownership. Differing interpretations of the legislation in respect of the valuation of land to be purchased by the state for restitution purposes and the valuation formulae recommended at various times by the state and its advisors are discussed. Some of the problems encountered in the implementation of the South African restitution program, including the highly emotional expropriation/confiscation issues, are mentioned. Three case studies based on these differing interpretations are given. The case studies illustrate the evolution of the interpretations of the legislation concerning land restitution valuations in South Africa. / School: Management sciences / M. Tech. (Real Estate)

This study briefly discusses land restitution in several countries in Europe and the Americas, the history of land deprivation in South Africa, and the legislation introduced to remedy the inequality of land ownership. Differing interpretations of the legislation in respect of the valuation of land to be purchased by the state for restitution purposes and the valuation formulae recommended at various times by the state and its advisors are discussed. Some of the problems encountered in the implementation of the South African restitution program, including the highly emotional expropriation/confiscation issues, are mentioned. Three case studies based on these differing interpretations are given. The case studies illustrate the evolution of the interpretations of the legislation concerning land restitution valuations in South Africa. / School: Management sciences / M. Tech. (Real Estate)

Not available / text

The lack of scientific research covering the factors contributing to the growth and regulation of the private security industry (PSI) in India and South Africa gave rise to the study. The study used qualitative research methods, a case study design and documentary analysis techniques, including personal interviews supported by a qualitative questionnaire and e-mailing the questionnaires to participants, to achieve the purpose and objectives of the study. The researcher interviewed seven participants from India personally and eight responded to the qualitative questionnaire sent by e-mail. The researcher conducted eight one-on-one interviews with South African participants and eleven members responded to the qualitative questionnaire sent by e-mail. The researcher carried out a pilot study to identify any shortcomings in the qualitative questionnaire. The study examined various theories on regulations and regulatory frameworks and considered the theoretical aspects of regulating the private security industry. This study confirmed that private security is growing at a rapid pace in India and South Africa, and the common factors encouraging growth include socio-economic factors like rapid growth and infrastructure, increasing urbanisation, growth of the middle class, poverty and unemployment, illegal immigration, growth in private property and increase in personal wealth. Indian participants especially, felt strongly that an increase in terror attacks is a key factor contributing to the rapid growth of the PSI, whilst South African participants confirmed, a fear of political violence and being scared of civil unrest were reasons for the increased presence of the PSI in the country. The participants corroborated that statutory-based legislation imposed by the Private Security Agencies (Regulation) Act 2005 and the Private Security Industry Regulation Act 2001 is not wholly effective in regulating the PSI in India. / Ukusweleka kocwaningo lwesisayense olwengamela izinto ezinomthelela ekukhuleni kanye nemitheshwana yolawulo kwimboni yonogada bezokuvikeleka yangasese i-private security industry (PSI) eNdiya naseNingizimu Afrika kwenze ukuthi kube nalolu cwaningo. Ucwaningo lusebenzise izindlela ze-qualitative research methods, i-case study kanye nethekniki yohlaziyo lwamadokhumende, okubandakanya nama-interview nabantu ziqu, ngokusekelwa wuhla lwemibuzo ebhaliwe ye-qualitative kanye nohla lwemibuzo ebhaliwe (questionnaires) ethunyelwe nge-email kulabo ababambe iqhaza, ukufezekisa izinhloso nezinjongo zocwaningo. Umcwaningi wenze ama-interview nababambi qhaza abayisikhombisa ziqu baseNdiya kanti abayisishagalombili baphendule imibuzo yohla ebhaliwe ye-qualitative oluthunyelwe nge-email. Umcwaningi ubuye waba nama-interview okubhekana ubusu nobuso nababambi qhaza baseNingizimu Afrika abayisishagalombili, kwathi abayishumi nanye baphendula uhla lwemibuzo ebhaliwe ye-qualitative ethunyelwe nge-email. Kwenziwe ucwaningo lokulinga (pilot study) ukubheka ukuntengantenga kohla lwemibuzo ebhaliwe ye-qualitative. Lolu cwaningo luhlole amathiyori ahlukahlukene ngokwenziwa kwemithetho yolawulo kanye nohlaka lwemitheshwana yolawulo, kanye nokubonelela izingxenye zethiyori yemitheshwana yolawulo lwemboni yonogada bezokuvikeleka yangasese. Ucwaningo luqinisekise ukuthi imboni yonogada bangasese bezokuvikeleka ikhula ngokuyisimanga eNdiya kanye naseNingizimu Afrika, kanti okuyixhumanisayo nokufanayo, kubandakanya ukukhula kwezinto eziphathelene nabantu nezomnotho njengokukhula ngesivinini kwezingqalasizinda, ukuya kakhulu kwabantu ezindaweni zamadolobha, ukukhula kwe-middle class, inhlupheko nokusweleka kwemisebenzi, ukungena kakhulu kwabantu ababuya kwezinye izindawo ngokungemthetho (illegal migration), ukukhula kwempahla yangasese kanye nokwanda kokunotha kubantu. Ababambi qhaza baseNdiya bona banemizwa eqinile yokuthi uhlaselo lwamaphekulazikhuni (terror attacks) yinto enomthelela kakhulu ukukhuleni kwemboni ye-PSI. Ababambi qhaza baseNingizimu Afrika bona baqinise ukwesaba udlame lwezepolitiki kanye nokwesaba izivungu-vungu zovukelwano lwabantu, yikho okube yizizathu zokukhula kobukhona be-PSI ezweni. Ababambi qhaza baqinise ukuthi imithetho efakelwe ye-Private Security Agencies (Regulation) Act 2005 kanye nomthetho we-Private Security Industry Regulation Act 2001 ayisebenzi ngokufanele ukulawula kahle imboni ye-PSI eNdiya. / Esi sifundo sibe ngunozala wokunqongophala kophando lobunzululwazi malunga nezinto ezincedisa ekukhuleni nasekulawulweni korhwebo lokhuselo lwabucala, iprivate security industry (PSI), kwilizwe laseIndia naseMzantsi Afrika. Isifundo sisebenzise indlela yophando lomgangatho, uyilo lwenkqubo engumzekelo, uhlalutyo lwemibhalo, udliwano ndlebe lobuso ngobuso nabantu ngabantu, oku kuxhaswa luluhlu lwemibuzo olubhaliweyo noluthunyelwe kubathathi nxaxheba ngeimeyile ukuze kuphunyezwe iinjongo zesi sifundo. Umphandi udlane indlebe nabathathi nxaxheba abasixhenxe abavela eIndia kanti abasibhozo baphendule uluhlu lwemibuzo yomgangatho kwi-imeyile. Umphandi uqhube udliwano ndlebe ubuso ngobuso nabathathi nxaxheba abasibhozo eMzantsi Afrika kanti abalishumi elinanye bona baphendule uluhlu lwemibuzo yomgangatho kwi-imeyile. Kwaqhutywa isifundo sokutshayelela ngenjongo yokuqonda ukuba akukho zikhwasilima na kuluhlu lwemibuzo yomgangatho. Isifundo siphonononge iingcingane okanye iithiyori ezingemigaqo nezakhelo zemigaqo yolawulo kwaza kwaqatshelwa imiba yeengcingane emalunga nokulawulwa norhwebo lokhuseleko lwabucala. Esi sifundo singqine ukuba ukhuselo lwabucala lukhula ngesantya esikhawulezayo eIndia naseMzantsi Afrika, kwaye izinto ezikhuthaza oku kukhula ziquka imiba yezentlalo noqoqosho njengokwanda okukhawulezayo nezibonelelo, ukwanda kweendlela zokuphila budolophu, ukukhula kwezinga loluntu eliphakathi (middle class), ubuhlwempu nentswela ngqesho, ukufudukela kwamanye amazwe ngokungekho mthethweni, ukwanda kokufumaneka komhlaba wabucala nokwanda kobutyebi babantu. Abathathi nxaxheba baseIndia bathi bacinga ukuba ukwanda kohlaselo ngabagrogrisi kuphambili ekuncediseni ukukhula korhwebo lokhuselo lwabucala. AbaseMzantsi Afrika bona bangqina ukuba uloyiko lobundlobogela bezopolitiko nokoyika uvukelo mbuso zizizathu zokwanda kobukho borhwebo lokhuselo lwabucala kweli lizwe. Abathathi nxaxheba bavuma ukuba imigaqo esekelwe emthethweni nebethelelwa nguMthetho Wokhuselo Lwabucala wama-2005, iPrivate Security Agencies (Regulation) Act 2005 kunye nePrivate Security Industry Regulation Act 2001 ayisebenzi ngokufezekileyo ekulawuleni urhwebo lokhuselo lwabucala eIndia. / Criminology and Security Science / Ph. D. (Criminal Justice)

The rapid increase and popularity of Unmanned Aircraft Systems (UAS) in civil usage around the world is due to their versatility. With advancement in technology across the globe, there are UAS of different sizes and capabilities in the market. It is imperative to note that the use and operation of UAS have numerous merits and equally, potentially poses serious risks to aviation safety, unlawful interference with States’ security as well as invasion of the privacy of persons. This reality poses a challenge to integration of UAS into the civil airspaces of different States. Accordingly, the international community developed the Chicago Convention that provides the principal framework to address the threefold concerns. At the international level, however, there is lack of a unified system of regulation of UAS. Consequently, the Chicago Convention requires States to develop national institutions and legal frameworks to not only effectively address these concerns, but also create a delicate balance between national security and right to privacy. This thesis evaluates how the legal, institutional and policy frameworks for UAS in the US, South Africa and Kenya have addressed the current needs and challenges in operation and integrating them into regulatory frameworks for civil aviation. It follows that the three States have developed constitutional frameworks, legislation, regulations, policies and strategic plans as they seek to address the challenges that emanate from integrating UAS into the civil aviation airspace. This encompasses ineffective enforcement mechanism of regulations. The thesis maps out experiences of integration in the three countries, emanating from research goals including investigating the extent to which existing international regulatory frameworks address the threefold concerns. The study establishes that the common thread running through UAS regulation is each country’s unique issues and paths to integration. Additionally, that the approach for integration of UAS into civil aviation needs be gradual and pragmatic. For this reason, this thesis recommends the development of institutional capacity, coordination and funding, and increase in regional efforts to revamp UAS integration efforts into civil aviation. / Public, Constitutional, and International Law / LL. D. (Public, Constitutional and International Law)