University of Macau / Institute of Chinese Medical Sciences

Zugl.: Berlin, Humboldt-University, Diss., 2008. / Includes bibliographical references.

“Outsourcing has been touted as the ideal way for organisations to reduce cost, focus on core business processes, improve services, enhance skills, reduce time-to-market and increase overall competitive advantage,” (Power, Bonifazi and Desouza, 2004). A pertinent question is therefore ‘Can South African companies in the pharmaceutical industry remain competitive by outsourcing, what is driving these companies to outsource and how effective has the initiative been?’ The purpose of the study is to identify the extent to which various key factors play an influential role in motivating pharmaceutical companies in SA to outsource. South African pharmaceutical companies as part of the global arena, have to continually assess the feasibility of manufacturing their products in-house or allowing contract manufacturers to manufacturer and or pack on their behalf. The research questions posed in this research were: why are companies outsourcing, what is outsourcing and what is happening amongst the South African pharmaceutical companies? The results of this qualitative rich study have shown that outsourcing in SA is not just about cost savings or reduction in product costs but that this process is able to afford the contract giver the ability to tap into additional capabilities (facilities, technology and skill) of their outsourcing partner. Outsourcing has enabled the contract manufacturers in SA to assist the contract givers in numerous areas such as cost reduction, cost saving, reduction in capital investment, increased flexibility and allowed the contract givers to focus on their core competencies. The implementation of off shoring may result in South African contract givers incurring additional ‘hidden costs’ which may be attributed to quality problems, reduced flexibility of transport, product write-offs (due to large volumes ordered), currency fluctuations and additional resources that may required (technology transfer, documentation review, and validation). The responses from the research questionnaires indicate that the key drivers of outsourcing in South African are aligned with those identified in global ii marketplace by Jiang and Qureshi; Copestake and Lau and Zhang (2006). The main drivers being profitability increase (cost reduction, cost saving and capital reduction), strategic considerations (focus on core competence, increased flexibility and to facilitate market penetration) and access to knowledge and skills. The key for the South African outsourcing service providers lies in ensuring that their clients are kept satisfied so that they can minimise the threat of offshore providers. The results of the study are line with Momme and Hvolby (2001) suggestions in which they advocate that organisations only outsource when suppliers have a comparative advantage and that an organisation proactively have a stronger focus on its internal core business areas. In SA governmental changes in regulations/ laws such as those addressing parallel importation, patents, foreign investors and trade would impact on the countries national competitive advantage. However although outsourcing is highly beneficial, organisations need to carefully manage the process, identify hidden costs, risks and initiate preventative measures to ensure success. This study was the first step towards conceptualising the impact of the key drivers, decision making and strategic issues on the South African pharmaceutical manufacturing industry. / Graduate School of Business Leadership / MBL

Mini-study project (MBA)--University of Stellenbosch, 2003. / ENGLISH ABSTRACT: This report reviews the global and South African pharmaceutical and biotechnology industries and provides an overview of the changes taking place within these two industries. It highlights the impact this relationship will have on a developing South African biotechnology industry. Since the 1980s the pharmaceutical industry has experienced phenomenal growth in sales and profits. By the mid 1990s drug sales exceeded USD250 billion. Today the pharmaceutical industry is dominated by multi-national corporations with extensive R&D budgets, widespread use of trademarks and patents and complex commercial process technology. However they face threats from depleted product pipelines, patent expiry on billion dollar drug products, generic competition, increases in drug approval times, costs and price pressures. The entrepreneurial biotechnology industry promises to solve a number of the pharmaceutical industry's problems. In recent years biotechnology companies proved more effective in the development of new molecular entities. They promise individualised therapeutics, novel and more efficacious drug discovery and development of preventative treatments. However the decrease in equity financing after 2001 left almost 40% of biotechnology companies with less than 1 year of R&D funding. The industry experienced losses again in 2002 and the world is divided over the ethical, environmental and economic implications of biotechnological applications. The biotechnology and pharmaceutical industries have a symbiotic but antagonistic relationship. The change in this relationship will hugely affect South Africa's ideals of developing a biotechnology industry. Various diseases plague South Africa including HIV/AIDS, TB, obesity, diabetes, hypertension and infective diseases. These diseases will have a huge impact on South Africa's society. Yet only 10% of global R&D funding is committed to third world diseases and existing drugs and treatments are either not effective or too expensive for developing countries. It is in this situation that biotechnology and the development of a biotechnology industry could playa major role in alleviating South Africa's health burden. South Africa is already capable in first generation biotechnology, but third generation applications holds the most promise. Developing countries face various obstacles and challenges, but all boast well for South Africa. The government has committed R400 million (over a three year period) to utilize South Africa's biotechnology potential. Further, the country has highly skilled researchers, indigenous plant and animal species, a diverse population and a favorable exchange rate (low R&D costs). / AFRIKAANSE OPSOMMING: Die projek ondersoek beide die globale en Suid Afrikaanse farmaseutiese en biotegnologie industrieë. Verder word die veranderinge wat plaasvind in die industrieë onder die soeklig geplaas. Die projek beklemtoon die impak wat die verhouding sal hê op 'n ontwikkelende biotegnologie industrie in Suid Afrika. Die farmaseutiese industrie het sedert die 1980s dubbel syfer groei getoon in omsete en wins. Teen die middel 90's het verkope van farmaseutiese middels US$250 miljard wêreldwyd oorskry. Vandag word die farmaseutiese industrie oorheers deur multi-nasionale korporasies met omvattende navorsing en ontwikkelings begrotings, algemene gebruik van handelsmerkte, patente en komplekse proses-tegnologieë. Ten spyte hiervan word die industrie bedreig deur leë produksie-lyne, verval van patente, miljard dollar farmaseutiese produkte, generiese kompetisie, verlengde produk-goedkeurings periodes en prys-mededinging. Die biotegnologie industrie met sy innoveerende eienskappe beloof om verskeie van die farmaseutiese industrie se probleme op te los. Onlangs het biotegnologie maatskappye getoon dat hulle meer effektief is in die ontwikkeling van nuwe molekulêre eenhede. Biotegnologie beloof nuwe en meer effektiewe produk-ontwikkeling asook beter individuele terapieë en voorkomende behandelings. Die industrie staar finansiële krisisse in die gesig. Slegs 40% van biotegnologie maatskappye het voldoende navorsing en ontwikkelings-kapitaal tot 2004. Dit is hoofsaaklik as gevolg van 'n afname in eienaars-finansiering na 2001. Die industrie as 'n geheel het weereens 'n verlies gelei in 2002 en die wêreld is verdeeld oor die etiese, omgewings en ekonomiese implikasie van biotegnologiese toepassings. Die biotegnologie en farmaseutiese industrieë het 'n simbiotiese maar tog vyandige verhouding. 'n Verandering in die verhouding gaan Suid Afrika se ideale om 'n biotegnologie industrie te skep grootliks beïnvloed. Suid Afrika gaan gebuk onder verskeie siektes insluitende MIVNIGS, TB, vetsugtigheid, diabetes, hipertensie en infeksie siektes. Hierdie siektes het 'n groot impak op Suid Afrika se samelewing. Tog word slegs 10% van die globale navorsings en ontwikkelingsfondse aangewend om 'n oplossing te vind vir derdewêreld siektes. Verder is bestaande produkte en behandelings oneffektief of onbekostigbaar vir ontwikkelde lande. Dit is in sulke gevalle waar biotegnologie en die ontwikkeling van 'n biotegnologie industrie 'n groot rol kan speel in die verligting van Suid Afrika se gesondheids-las. Suid Afrika is vaardig in eerste-generasie biotegnologie, maar wêreld wyd hou derde generasie biotegnologie die meeste belofte in. Die tegnologie is tot op hede onderbenut in Suid Afrika. Ontwikkelende lande staar verskeie uitdagings in die gesig, maar Suid Afrika het talle sterk punte. Die regering het R400 miljoen (oor 'n drie jaar periode) beskikbaar gestel vir die ontwikkeling van Suid Afrika se biotegnologie potensiaal. Die land beskik ook oor navorsers van hoogstande gehalte, onbenutte inheemse plante en dier spesies, 'n diverse populasie en 'n gunstige wisselkoers (lae navorsings en ontwikkelings kostes).

Thesis (MBA)--Stellenbosch University, 2003. / ENGLISH ABSTRACT: With globalisation and the accompanying increase in international trade there is a great drive towards performing risk assessments on the quality of products. Such assessments are of particular importance within the food and drug industry, so much that this approach is also being adapted by the FDA in their analysis of the quality of products and probable risks to it. The pharmaceutical industry is heavily regulated to reduce or eliminate the production and distribution of poor quality products. Pharmaceuticals have to be of high quality as people's lives depend on it. Many pharmaceutical companies import raw materials from international manufacturers or international agents. In most cases the raw material or the products have to go through a long and complicated supply chain. The more parties involved in the supply chain, the greater the risk to product quality. Supply chain partnerships have therefore become critical to manage these risks to product quality throughout the supply chain. In order to manage risks to product quality, it has become vital to perform product quality risk assessments, especially through the supply chain. In this study the Failure Mode Effect Analysis (FMEA) is used to perform a risk assessment of risks to product quality throughout the supply chain. To obtain the criticality of the risks the Failure Mode Effect and Criticality Analysis (FMCEA) is applied. Quality improvement systems which contribute towards managing the risks to product quality are also discussed in this report. By managing quality risks to pharmaceutical products along with using quality as a strategy, the pharmaceutical company contributes towards improved health for patients as well as customer satisfaction, business success and excellence. / AFRIKAANSE OPSOMMING: Die toepassing van die analise van die risiko op produkte is vinnig besig om te vermeerder. Die FDA gaan dit toepas in hulle analise van die kwaliteit van produkte en die risiko wat daarmee gepaard gaan, in die voedsel en medisyne bedryf. Die farmaseutiese industrie word baie streng gereguleer om te verhoed dat die produksie en distribusie van swak kwaliteit produkte ervaar word. Farmaseutiese produkte moet van hoë gehalte wees, omdat die gesondheid van pasiënte daarvan afhang. Baie farmaseutiese maatskappye bestel rou materiale van oorsese makelaars en in baie gevalle moet die rou materiale deur 'n lang en gekompliseerde voorsieningsketting gaan. Hoe meer agente betrokke is, hoe hoër word die risiko met respek tot die kwaliteit van die produk. Die voorsieningsketting speel 'n kritiese rol om te verseker dat risikos beheer kan word, omdat elke party verantwoordelik is vir die lewering van kwaliteitsprodukkte. Om te verseker dat risikos beheer word, het dit belangrik geword om risiko analise te doen op die kwaliteit van produkte, veral wanneer in die voorsieningsketting. In hierdie studie word die "Failure Mode Effect Analysis (FMEAJ' gebruik om 'n risiko analise te doen met betrekking tot risikos op 'n produk se kwaliteit wanneer in die voorsieningsketting. Die "Failure Mode Effect, and Criticality Analysis (FMECAJ', word ook toegepas om te bereken hoe krities die risiko is. Verbeteringstelsels wat bydra tot die beheer en kontrole van risikos vir produk kwaliteit word ook in hierdie studie bespreek. Deur die risikos te beheer op die kwaliteit van produkte, dra die farmaseutiese maatskappy by tot beter gesondheid vir pasiente, en verseker klient satisfaksie en suksesvolle besigheid.

Thesis (MBA)--Stellenbosch University, 2014. / In South Africa, the retail pharmacy market has changed dramatically with the introduction of legislation allowing a non-pharmacist to own a pharmacy as well as the regulation of medicine prices, which has affected the profitability of independent community pharmacies. These regulations have caused a shift in the status quo in that major corporate retailers have successfully entered the retail pharmacy market. The independent community pharmacy owner has to manage and finance his/her own pharmacy and does not have access to vast financial resources such as the major corporates forcing some of them to close down. The aim of the research was to investigate in more detail the competitive strategies independent community pharmacies have in place by utilising qualitative empirical research to address the main research question and research objectives. All the respondents acknowledged the importance of personal customer service as a key success factor in their strategic planning process. The research results showed that independent community pharmacies cannot compete with corporate-owned pharmacies on their dispensary as they do not have the financial resources in comparison to corporate retailers. Respondents realized that by leveraging their front-shop offering and offering products to customers based on their needs and wants, they will be in a better position to compete. In order to attract and retain their customers, the respondents recognised the significance of offering value-added services to suit the needs of the community. Respondents highlighted the importance of understanding the market to improve their business as well as moving from a convenience store to a one-stop destination store for customers. Although the respondents agreed that marketing one’s products, services and promotions were important in order to create awareness of their offering, and considered a definite method to attract new customers to the store, some pharmacy owners stated they were not financially in a position to do so. Employee retention is currently not a concern due to low turnover, with respondents feeling that the current work atmosphere and culture are conducive to the retention of staff. Research results showed that proper inventory management is essential in order to ensure that the product offering addresses the needs of the clientele. Respondents seem to be concerned that further legislative changes may adversely affect their profit margins but appear to be hopeful regarding their sustainability into the future. The research highlighted the value of managerial capability and expertise enabling independent community pharmacies to pose a viable threat to the corporate retailer operating within its vicinity. To ensure competitiveness in the retail pharmacy sector, the independent community pharmacy needs to adapt and continue to redefine itself in the face of significant challenges in the health landscape by developing a sustainable strategy based on the following recommendations: - Expanding front-shop retail. - Offering value-added services. - Implement integrated business solutions. - Create brand awareness with an increased marketing presence. - Sponsor employee training interventions and/or attendance at industry seminars. - Implement employee incentive programmes. - Having defined and documented standard operating procedures and processes in place. - Joining buying groups in an attempt to increase buying power.

A double case study applying action research methodology was conducted in two pharmaceutical preparation manufacturers in the Netherlands to improve their manufacturing systems by implementing time-based manufacturing (TBM) practices. Following the diagnosis phase, the situation of each Company was analysed and suitable improvement interventions were selected for implementation in the Case Companies. At the end of the action research project, semi-structured interviews were taken in each Company a year later, and the achieved results of the improvement programmes were collected and analysed. This research extends the existing theory of time-based competition and demonstrates that TBM practices apply also in the pharmaceutical preparation manufacturing industry. Furthermore, this study shows how to improve TBM practices and reduce the throughput time by providing the route for improvement and implementation. Although the first Case Company did not improve the core TBM practices and manufacturing performance, its infrastructure improved through the implementation of an ERP system and further enhancement of its quality management system, illustrating that the design of the infrastructure is a key factor to become a time-based competitor. The second Case Company succeeded to improve the 2 TBM practices and throughput processes resulting in the reduction of the order cycle time and increase of the delivery dependability. Based on the data of the two Case Companies, this study demonstrated the relationship between these two manufacturing performance parameters, which indicates that manufacturers may strive for both delivery speed and delivery reliability using the same improvement plan. Adopting TBM is a long journey of many years and needs a continuous improvement infrastructure.

This thesis addresses corporate approaches to CSR stakeholder engagement in the pharmaceutical industry in the UK and Germany. Its objective is to undertake mainly exploratory qualitative research to investigate how the selected sample manages CSR. The data was primarily accessed and collected from senior executives within major pharmaceutical companies. Multiple research methods were employed to gather rich new empirical evidence which focuses on the CSR practices and perceptions of CSR managers in both countries. To examine how this 'sensitive' sector responds to what could be termed the 'CSR Challenge', a critical realist perspective and six codes were chosen to map the practices and to compare similarities and differences between the two countries. This research contributes to the academic literature in this field by filling significant gaps in an area which was previously under-investigated. Ultimately, the findings are employed to examine a prespecified framework which was originally developed by the author based on secondary data in separate research. Overall, the results inform, re-examine, and improve this recently published framework. The updated explanatory framework which results from the research is the main conceptual contribution of the thesis. It serves as a management tool which includes the contextual factors which influence decision-makers' practices and perceptions portrayed as a set of inter-related management steps. This new conceptualisation is designed to be of practical use for decision-makers when managing their stakeholder engagement activities. As a result, this research is essentially applied and normative in nature. In addition, this work presents an original contribution to the literature in its field which should be of interest to academics.

本碩士論文裡的研究主要設計用來檢測目前現有的國際化理論，以依據公司1970至1999年的母公司年報來研究一間多國企業的藥廠 — 必治妥施貴寶其部分具有知名度的代表性產品之國際化路徑如此的研究方法。本論文的最終目標就是透過這樣的實務研究來回答以下問題來挖堀出現有國際化理論的一些缺口及提供寶貴的意見來修正這些缺口，研究問題如下： i. 一間多國企業藥廠通常採用何種進入策略，而這些策略是否會隨著時間而改變？是否有任何經驗傳承的證據？ ii. 多國企業所選擇進入的外國市場是否會隨著時間的改變而改變？如果有，是否一間多國企業會先選擇進入與其母國文化較相近或地理位置較相近的國家？ iii. 哪一個國際化理論比較適合用來描述必治妥施貴寶其國際化路徑？ 本研究的結果有以下四項重要的發現： 1. 在某些國家的進入策略的改變是循序漸進的，但是在某些國家則是有同時間採用兩種以上不同的進入策略。 2. 循序漸進進入策略的改變在九十年代必不明顯。 3. 必治妥施貴寶所選擇進入的外國市場會隨著時間的改變而改變，而且其新產品會選擇與其母國美國文化距離較近的國家先進入，然後再慢慢的選擇進入離美國文化距離較遠的國家。但是這樣的證據並不是相當明顯。其他的因素也會影響一家多國企業在國外市場選擇的決定。 4. 部分結果顯示出一些經驗傳承的現象，在九十年代必治妥施貴寶所開發出的產品相對於八十年代所開發出的產品在全球上市所花的時間明顯較短。 結論就是本研究結果有部分與循序漸進理論為主的國際化理論 – ‘The Stages Internationalization Theory’一致，此理論主張國際化是一種循序漸進對於國際市場知識的累積及資源的投入。部分結果則顯示出此理論尚有其不足之處。此理論是在七十年代被Johanson及Vahlne兩位學者所提出，當時的國際企業環境與現在比起有相當大的差異，因此此理論在某種程度上太過簡化，而且並不適用於所有的產業。有許多會影響某企業其國際化路徑的因素應該一併納入，尤其在面對像製藥產業如此特別的產業，因素例如不同國家的製藥產業法規、產品特性、專利保護、在不同時間點的國際企業環境都會影響企業的國際化路徑的發展。因此後續與本碩士論文類似的實務研究需要更充分的資料來檢測現有國際化理論的主張。 / This Master thesis is designed to test the currently existing internationalization theory by studying the internationalization processes of some of the representative products of a foreign multinational pharmaceutical firm – The Bristol-Myers Squibb using the data contained in the annual reports of the period from 1970’s to 1990’s. By answering the following questions, the ultimate goal is to provide useful suggestions that will help to make corrections to any possible flaws in the Internationalization theory as they are uncovered during the course of this study by answering the following questions: i. What entry modes to foreign markets does a multinational pharmaceutical firm adopt and do entry modes change over time? Is there any sign of experience transfer? ii. Do foreign markets served by a multinational pharmaceutical firm also change over time? iii. Which theory depicting the internationalization process of firms is more applicable to Bristol-Myers Squibb? The results of the analysis of the data show four important findings: 1. Progressive changes in entry modes took place in certain countries and the employment of multiple entry modes was also observed. 2. The progressive changes in entry mode were barely observed during the 1990’s. 3. The choices of foreign markets did change over time and the marketing activities of new products tended to commence in countries that are the most culturally proximal from the U.S., and then gradually shifted to countries that are more culturally distant from the U.S. However, other factors might also influence a firm’s choice in the foreign markets apart from culture. 4. There seemed to be a sign of experience transfer since the some of the results showed that the time it took to introduce a product developed in the 1980’s in foreign markets was relatively shorter than the time it took to launch a product of the 1990’s. In conclusion, the results of study were partly consistent with ‘The Stages Internationalization Theory’ which argued that the internationalization was a process of knowledge accumulation of foreign markets and resource commitment gradually. However, there might be some flaws in the theory which needed to be refined. The theory was developed in the 70’s and it might not be perfectly applicable to describe the internationalization processes of the firms in every industry. It should also take other factors apart from culture into considerations such as the nature of products, regulations and policies of different countries, competitive scope of the industry or the international business environment at different time points, especially when dealing with some special industries such as that of the pharmaceuticals in which regulations of different countries, patent protection and the nature of the products might influence the pattern of internationalization of the firms. However, further empirical studies with more adequate data would be necessary in the future in order to justify the propositions of different theories of internationalization.

<p>The pharmaceutical industry is one of Sweden’s most important export industries with 6% of total exports. The purpose of this thesis is to analyse which factors affect Sweden’s ex-port of pharmaceutical products. Further, the different pharmaceutical products group Sweden exports will be identified. The modern trade theory, the monopolistic competition model, the product life cycle theory and the gravity equation are used to explain and to un-derstand the problem at hand.</p><p>To analyse the problem, data of Swedish export of pharmaceutical products from 1997 to 2003 was used to the 176 destination countries Sweden exported to during the time period. The following factors were used as independent variables; distance, Gross Domestic Prod-uct (GDP) /capita, Area, Population, dummy variable for EU-membership, dummy vari-able for English or Scandinavian speaking countries, dummy variable for bordering to Sweden, dummy variable for same religion as Sweden and a dummy variable for countries that are not land-locked.</p><p>The findings coincide with previous studies in the manner that distance and GDP/capita have a major impact on the sales abroad of pharmaceutical products. Also, countries with a larger population are importing more than countries with a smaller population. However, the strong affinities between the exporter and the importing countries found in previous studies were not found in the export of pharmaceutical products. Further, Sweden exports most of the product group that includes medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses.</p> / <p>Läkemedelsindustrin är en av Sveriges viktigaste exportindustrier med 6 % av den totala exporten. Syftet med denna uppsats är därför att analysera vilka faktorer som påverkar dess export. Vidare, de olika exportgrupperna av läkemedel som Sverige exporterar kommer att identifieras. Den moderna handelsteorin, monopolistisk konkurrens, produktcykelteorin och gravitationsmodellen används för att förklara och förstå det uppstådda problemet.</p><p>För att analysera problemet så används Sveriges export av läkemedel från 1997 till 2003 för alla 176 destinationer. Följande faktorer används som oberoende variabler; distansen, BNP/capita, arean, folkmängd, dummy variabel för EU-medlemskap, dummy variabel för engelsk- eller skandinaviskspråkiga länder, dummy variabel för gränsande länder till Sverige, dummy variabel för länder som har samma religion som Sverige, samt en dummy variabel för länder som angränsar till vatten.</p><p>Resultatet överensstämmer med tidigare forskning att avståndet och BNP/capita har ett stort inflytande av exporten av läkemedel. Likaså länder med ett stort invånarantal importe-rar mer än länder med ett mindre invånarantal. Däremot, det starka släktskapet mellan ex-portören och de importerande länderna som funnits i tidigare studier observerades inte i exporten av läkemedel. Vidare, Sverige exporterar mest av produktgruppen som innehåller medikamenter bestående av blandade eller oblandade produkter för terapeutiskt eller profy-laktiskt bruk.</p>