A thesis submitted to the Faculty of Health Sciences, University of the Witwatersrand, in fulfilment of the requirements for the degree of Doctor of Philosophy. Johannesburg, 2017. / Background: Generic drugs provide a safe, effective and affordable alternative to medicines whose patent protection has expired. The affordability of generics improves access to medicines and thus improves health outcomes. The generic pharmaceutical industry is complex; profitability depends on the number of other generics on the market. Objective: To develop a model that explains structural relationships in the off-patent market between the price of a generic drug and the characteristics of a drug, formulation market and regulatory processes in the South African pharmaceutical industry. Sources of Data: Innovators’ drugs and their generic equivalents were selected from all the molecules whose patents expired between 1999 and 2012. Data were obtained from IMS Health (Total Private Market Report) and National Department of Health (Database of Medicine Prices) for the patents’ expiration dates, prices, sales, launch dates of generics, therapeutic groups, schedules, and dosage forms of drugs in the sample. Principal Findings: Generic entry into the local pharmaceutical industry is low, slow and selective. The developed model for this study identified seven market variables that were found to have an influence on the prices of generic drugs in South Africa. The determinants of generic entry are the market size of the on-patent innovator product, and the complexity of manufacture of a dosage form. The introduction of the transparent pricing system has had a significant impact in reducing the average unit prices of generics in South Africa. However, there appears to be policy incoherencies between the public health and industrial policies of the South African government as it pertains to pharmaceuticals. The erosion of the manufacturing capacity in South Africa could potentially be attributed to the pharmaceutical pricing policy. The overreliance on pharmaceutical imports for satisfying local consumption poses a risk to the security of supply of medicines in a country that has a high burden of diseases. Conclusion: The introduction of legislative reforms related to the pricing of medicines in South Africa has largely yielded positive results in making medicines to be more accessible. Policy-making requires monitoring and evaluation programmes and inclusivity across all the stake-holders. / LG2018

Thesis (MBA)--Stellenbosch University, 2000. / ENGLISH ABSTRACT: This study is essentially an investigation into perceptions that exist in the medical field with regards to generic medicines and generic substitution. The study was conducted via the sampling of a variety of physicians, specialists and pharmacists in the Cape Peninsula. The primary test for these perceptions was the application of a five page questionnaire that the targeted sample group had to complete. South Africa entered a new era on political, social and economic levels with the election of a new democratic government. The reality is that South Africa is becoming more and more a third world country with deteriorating systems of health care and education, as a direct result of a shortage of funds and inadequate management or total lack thereof. It has also become more and more evident recently that this country is experiencing a "brain-drain", in that experienced and highly qualified people are leaving the country for mostly other first world countries, because they can no longer operate efficiently and effectively under the constraints imposed upon them by a shrinking health care budget. Government and private health departments constantly have to face the battle of containing costs so that they can operate in the way that they are supposed to. Unfortunately, with the constant escalation in the prices of medicine every year combined with a limited availability of funds, the problem just becomes worse every day with patients and medical aids suffering the most. One possible way in which an attempt could be made to reduce costs is to decrease the expenses of medicine, making more money available in other areas, or that the need for more medicines could be satisfied via having more money available as a result of these savings. Generic medicines are known to be less expensive than their ethical counterparts and can therefore contribute greatly to savings in this area, seeing that generic medicines mostly sell at 40%-50% of the price of the original. There are obviously more issues involved than just costs: the ethical issue of moral support to the ethical manufacturers that have done all the research and development of the original drug that now becomes "copied"; the issue of.quality and reliability of these "copycat" medicines; and the issue of the role that people in the medical field, government and other bodies should play in containing costs. These issues were addressed in the form of statements in the questionnaire and opinions were tested to see what perceptions exist, so that the marketers of medicines would know how to formulate their marketing plans and strategies in order to attain a bigger market share, or how to protect their current share of the market. The information should also prove handy to government and private health care organisations that should endeavour to contain costs wherever they can, seeing that they operate within the constraint of an allocated budget. / AFRIKAANSE OPSOMMING: Hierdie studie projek is essensieel 'n ondersoek na persepsies wat bestaan in die mediese veld met betrekking tot generiese medisynes en generiese plaasvervanging. Vir die doel van die studie is "mediese veld" gedefinieer as die verskillende kategorieë van mediese dokters en aptekers wat elke dag met die vraagstuk te make het. Die steekproef was dus mediese dokters, spesialiste en aptekers in die Kaapse Skiereiland. Die primere toetsinstrument was 'n vyf-bladsy vraelys wat 35 stellings bevat het waarin 8 faktore verskans was waarvoor die navorser getoets het. Suid-Afrika het 'n nuwe era betree met die daarstelling en verkiesing van 'n nuwe demokratiese regering van nasionale eenheid waarin alle Suid-Afrikaners deelname het. Die realiteite van Suid-Afrika vandag is dat dit meer en meer sy derde wêreld komponente openbaar waarvan die bestaan vantevore deur die eerste wêreld komponent geïgnoreer is. Die resultaat is dat gesondheidsorg en opvoedkundige sisteme aan die verkrummel is vanweë 'n tekort aan fondse asook oneffektiewe bestuur. Dit is dan ook onvermydelik dat 'n groot aantalleiers en kenners op hierdie gebiede besluit om die land te verlaat en na hoofsaaklik eerste wêreld lande emigreer, waar hulle in 'n veel mindere mate te kampe het met die probleme van swak bestuur en veral onder befondsing in die onderskeie areas van hulle spesialiteit. Dit laat 'n gaping wat gevul moet word deur swakker bestuur wat die probleem vererger. Regering- en privaat mediese departemente gaan gebuk onder die las van krimpende begrotings en 'n stygende vraag na mediese sorg, medisynes en ander geriewe. Dit is ook 'n voldonge feit dat mediese tariewe bly styg, dat medisynes konstant al hoe duurder word en dat daagliks waargeneem word dat daar 'n ondervoorsiening van personeel en medikasie in hospitale en ander gesondheidsorganisasies is. Die partye wat aan die kortste end trek is die pasient en die mediese fondse. Een moontlike wyse waarop hierdie probleem van stygende kostes aangespreek kan word is om die uitgawes op medisynes te beperk sonder om minder medisynes te koop, sodat meer geld beskikbaar sal wees vir ander behoeftes. Dit is bekend dat generiese medisynes heelwat goedkoper is as hulle etiese "broers" en dat die gebruikmaking hiervan kan lei tot besparings so groot as selfs 60% en meer. Daar is duidelik meer vraagstukke betrokke rondom die hele aangeleentheid van generiese medisynes en generiese plaasvervanging soos: die etiese vraagstuk aangaande morele ondersteuning aan die etiese firmas wat al die navorsing en ontwikkeling van die oorspronklike produkte doen en wat nou net gedupliseer word deur die generiese vervaardigers; die vraagstuk aangaande die betroubaarheid en kwaliteit van hierdie "duplikate"; asook die vraagstuk rondom die rol wat persone in die mediese veld en regerings- en- privaatinstansies moet vervul in die bekamping van stygende kostes. Hierdie vraagstukke is geadresseer in die vraelyste as stellings en opinies is getoets om vas te stel wat die huidige persepsies rondom die aangeleentheid van generiese produkte en generiese plaasvervanging is. Die belang van die kennis van hierdie opinies en persepsies is dat dit onontbeerlike inligting verskaf aan die bemarkers van farmaseutiese produkte en medisynes aangesien 'n bemarkingsplan en bemarkingstrategie hier rondom gevorm kan word, sodat maniere uitgewerk kan word om markaandeel te vergroot of om markaandeel te behou.

A thesis submitted in fulfilment of the requirement for the degree of Doctor of Philosophy of the Faculty of Humanities of the University of the Witwatersrand, Johannesburg. / This dissertation attempts to document the social life of Indian generic pharmaceuticals within the broader material culture of pharmaceuticals in Johannesburg. Foregrounding the question of value created in circulation, the study explores how conduits of generic pharmaceutical flow are saturated with the global politics of humanitarianism, locally embedded profitmaking efforts by businesspersons based on risk, cultural moorings of pharmaceutical relations, and historical specificities of locations in which pharmaceuticals have been mobilized for consumption. The central method is the ethnography of circulation. By documenting the ‘moral claims’ of Indian pharma capital as manifested in the public culture of pharmaceutical business, the discussion places the intersectionality of moral and material transactions at the centrestage of pharmaceutical sales and the creation of value / MT2017

Thesis (MBA)--Stellenbosch University, 2011. / This study analyses the effects of generic medicine competition on the market share growth and pricing of originator brand medicine in the South African private pharmaceutical market. The study is based on five years (2005 to 2011) of IMS Health market share data for 39 originator brand drugs that have been exposed to competition from generic substitutes from 2001. The results show that, for all the drug molecules included in the study pooled together, the price of an originator brand medicine relative to the weighted average price of its generics has a significant negative impact on the change of its market share. Results for the molecules pooled according to anatomical classes, as well as each molecule separately, show that in four out of the nine classes represented in the study and nine out of the 39 molecules the relative price of the originator brand medicine had a significant negative impact on its change in market share. The manufacturers and marketers of generic medicines would be well advised to offer their medicines at significantly discounted prices compared to the originator brands, as the results suggest that the market penetration of the generic product may depend heavily on the price the generics are offered at. Investigations into the prices of the originator brands in relation with the number of generic equivalents in the market show that the number of generics available in a specific market has a significant positive impact on the relative price of originators, thereby making originators relatively more expensive compared with their generic competitors, while at the same time the results show that the absolute price of the originator brand medicines declines as the number of generic equivalents in the market increases. This indicates that, from a policy perspective, reducing the barriers to entry for generic medicine once originator patents expire may have a significant role to play in reducing the cost of pharmaceutical drugs in the South African market.

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.