Thesis (LL.M.)-University of Toronto, 2005. / Cover title. Includes bibliographical references (p. 150-159).

Thesis (Ph. D.)--University of Washington, 1999. / Vita. Includes bibliographical references (leaves 146-156).

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

Background. Good health care is becoming increasingly unaffordable. A wider use of generic medicines offers significant cost savings. As the family practitioner is the gatekeeper in prescribing medicines, his attitude towards generic medicines is crucial. The factors that influence family practitioners' prescription of pharmaceuticals require investigation. Objectives. The primary objective of this study is to assess attitudes and perceptions that family practitioners have towards generic medicines and evaluate factors that influence its prescription. The secondary aim is to assess the individual characteristics and personality traits of family practitioners that may impact on generic prescription. Methods. This study is a convenient sample of 198 family practitioners that are surveyed by means of a questionnaire. Responses were based largely on a Likert scale and evaluated by factor analysis. Results. Using factor analysis, five factors identified in the order of importance are as follows: 1) Patient factors: It is primarily the patients' disease profile and their financial capacity that determines the use of generic versus ethical drugs. 2) Clinical autonomy of the family practitioners: Family practitioners resent their clinical decisions being challenged by managed care organisations. 3) Strategies promoting generics: Improved marketing by the generic pharmaceutical industry and the provisions of acceptable financial incentives are likely to promote wider use of generics. 4) Cost of medicines: Most family practitioners are price-sensitive. A further reduction in the price of generic medicines is therefore likely to increase the use. 5) Specialists' opinion: Specialists use fewer generics and their choice of medication is respected by family practitioners. A wider use of generic medicines by specialists will positively impact on generic prescription by family practitioners. Personality traits and individual characteristics of the family practitioners do not affect their prescription of generic medicines. It is noted that most family practitioners have encountered specific instances of reduced efficacy, an increased side-effect profile, substandard packaging, erratic availability and poor patient confidence with the use of generic drugs. Conclusion. In order to bring about a reduction in the healthcare costs by promoting wider use of generics, different stakeholders in the industry need to act synergistically. All stakeholders need to increase the awareness of generic medicines by continuing health education. Specific recommendations for the generic pharmaceutical industry include increased marketing, further reduction in the price of generics and implementation of research and surveillance studies to ensure satisfactory clinical efficacy of their drugs. Medicines Control Council need to closely monitor the number and quality of available generic medicines. Managed care organisations need to respect the clinical autonomy of family practitioners and work closely with them. Finally, acceptable and ethical incentives need to be considered for family practitioners, the gatekeepers, to achieve the objective of wider use of generic medicines. / Thesis (M.B.A.)-University of Natal, 2001.

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

Since the implementation of Directive 2004/48 EC on the Enforcement of Intellectual Property Rights in Sweden there is today a possibility for pharmaceutical companies holding a patent to issue interim injunctions against a generic company on the grounds of an attempt or preparation to a pharmaceutical patent infringement. It has been shown that one of the earliest steps in which a generic company may infringe a pharmaceutical patent is to offer the generic drugs onto the market. However, since the implementation of the attempt and preparation rule in the Swedish Patent Act questions have been raised as to in what stage interim injunctions may be issued against an attempt or preparation to offer generic drugs onto the market made by generic companies. This thesis has therefore intent to investigate at what stage interim injunctions may be applied for against a generic company on the grounds of an attempt or preparation to offer generic drugs. In the thesis the writer argues that in order for an attempt or preparation to offer generic drugs to exist an overall assessment must be made of the particular situation and that there is no specific principles to follow in order to determine either an attempt or a preparation to offer generic drugs. However, some guidance might be brought from Danish case law in order to establish a preparation to offer generic drugs in Sweden.

This was a study which sought to investigate the perceptions and experiences of private health care providers in Mafikeng, North West Province about generic medicines. The escalating cost of medicine in South Africa and elsewhere in the world has necessitated government intervention to come up with strategies to make health care accessible and affordable to the majority of the people. In South Africa, the Medicine and Related Substances Control Amendment Act (Act I0I of 1965), was implemented in May 2003. The Act makes it compulsory for pharmacist to offer patients generic medicines, apart from exceptions listed by the Medical Control Council and, if substitution takes place, to inform the doctor. The study was a prospective, cross- sectional survey of private health care providers in the greater Mafikeng area using a self- administered structured questionnaire. Participants received a structured questionnaire by hand mail and were given the same time to complete it. The questionnaires were them collected from their respective rooms. The main outcome measures were age, level of education, current occupation/profession and their perception and experiences about generic medicines. The total number of respondents was thirty two (32) out of forty (40) private health care providers who received the copies of the questionnaires. One questionnaire was incompletely answered and was therefore excluded from the final analysis. Seven questionnaires were returned unanswered. Age ranged from 26 to 51 and all had one or two university degrees. On average, private health care providers in Mafikeng perceived generic medicines and patent medicines to be identical and bioequivalent. Majority of the respondents prescribed generic medicines as their first line of treatment and were aware of the mandatory generic substitution law. According to the respondents, the majority of patients were not well informed about generic medicines. Majority of respondents were satisfied with the safety, quality, performance characteristics, intended use and route of administration of generic medicines. There is a need for a common essential drug list that will be used by all medical aids schemes in South Africa, wider generic prescribing in both the public and private health sector, speeding up the process of manufacturing generics, health care providers complying fully with the mandatory generic substitution law, parallel importation of generic medicines when a need arises and a widespread promotional campaigns targeting mainly consumers and health professionals. / Mini dissertation (M.B.A. (Financial Man.) North-West University, Mafikeng Campus, 2004

Thesis (Ph. D.)--University of Melbourne, Dept. of Political Science, 1997. / Typescript (photocopy). Includes bibliographical references (leaves 282-313).

Σήμερα η επιστήμη υπόσχεται νέες ανακαλύψεις που θα μας επιτρέπουν να ζούμε όχι μόνο περισσότερο αλλά και καλύτερα. Πρωτεύοντα ρόλο σε αυτή τη διαπίστωση κατέχει η φαρμακοβιομηχανία, όπου μέσω της συνεχούς έρευνας και ανάπτυξης παράγει νέα, καινοτόμα, πρωτότυπα φάρμακα. Τα πρωτότυπα φάρμακα εξακολουθούν να κατέχουν ηγετική θέση στην παγκόσμια φαρμακευτική αγορά, παρόλο που μετά τη λήξη της πατέντας τους δέχονται έντονες πιέσεις από την παραγωγή των αντίστοιχων γενοσήμων φαρμάκων. Είναι απαραίτητο να τονιστεί ο σημαντικός ρόλος των πρωτοτύπων στην προστασία της δημόσιας υγείας, όταν μάλιστα στην ελληνική αγορά έχουν εισέλθει μια πλειάδα γενόσημων φαρμάκων, υπό το μανδύα της οικονομικής κρίσης και της περιστολής των φαρμακευτικών δαπανών. Μέσα σε αυτό το πλαίσιο, η παρούσα διπλωματική εργασία προσπαθεί να αναζητήσει τους λόγους και τα κίνητρα της συνταγογράφησης των πρωτότυπων φαρμάκων από τους Έλληνες γιατρούς, μέσα σε ένα ταραχώδες συνεχώς μεταβαλλόμενο εξωτερικό περιβάλλον. Ουσιαστικά λοιπόν αναζητήσαμε ποιοι είναι αυτοί οι παράγοντες που κάνουν τους γιατρούς να συνταγογραφούν τα πρωτότυπα φάρμακα και πως αυτοί σχετίζονται με μια σειρά εξωτερικών παραγόντων. Τα ευρήματα της μελέτης προέκυψαν από τις απαντήσεις που έδωσαν 83 γιατροί διαφόρων ειδικοτήτων. Για την επιλογή των γιατρών δόθηκε έμφαση στη συμμετοχή ειδικοτήτων που έχουν υψηλή συνταγογράφηση, με κύριες ειδικότητες τους παθολόγους και τους ορθοπεδικούς. Η έρευνα πραγματοποιήθηκε σε γιατρούς των περιοχών των νομών Αχαΐας, Ηλείας και Κεφαλονιάς. Τα σημαντικότερα συμπεράσματα που προέκυψαν μετά τη στατιστική ανάλυση των απαντήσεων που δόθηκαν ήταν: 1) η πολύ μεγάλη αποδοχή που εξακολουθούν να έχουν τα πρωτότυπα φάρμακα από την ελληνική ιατρική κοινότητα, ακόμα και όταν υπάρχουν αντίστοιχα γενόσημα, 2) το ευρύτερο πλαίσιο των παραγόντων που επηρεάζουν τη συνταγογραφία των γιατρών είναι: α) η αποτελεσματικότητα, β) το κύρος/όνομα της φαρμακευτικής εταιρίας, γ) η τιμή του φαρμάκου, δ) η καινοτομία, ε) η ασφάλεια/ανεπιθύμητες ενέργειες, 3) οι εταιρίες με πρωτότυπα φάρμακα επηρεάζουν τη συνταγογραφία των γιατρών ανάλογα με το κύρος και το όνομά τους, 4) η άσχημη οικονομική κατάσταση που επικρατεί στη χώρα καθώς και τα μέτρα που έχουν ληφθεί στο χώρο της υγείας, δείχνουν να στρέφουν κάποιους γιατρούς από τα πρωτότυπα προς τα γενόσημα, 5) οι «διαμορφωτές γνώμης» επηρεάζουν σχετικά τη συνταγογραφία των Ελλήνων γιατρών, μόνο όμως όταν εμφανίζονται σε συνέδρια και συμπόσια ως ανεξάρτητοι επιστήμονες, ενώ δεν την επηρεάζουν καθόλου ως προσκεκλημένοι ομιλητές σε εταιρικές εκδηλώσεις, 6) οι πρακτικές marketing των εταιριών με πρωτότυπα υπερτερούν από τις αντίστοιχες των εταιριών με γενόσημα, 7) ο ιατρικός επισκέπτης επηρεάζει θετικά τη συνταγογραφία των γιατρών όταν είναι καλά ενημερωμένος για το φάρμακό του, 8) παρατηρείται τάση των γιατρών για χαμηλό ρίσκο στη συνταγογράφηση, 9) τα γενόσημα φάρμακα είναι πολύ πιο πιθανό να συνταγογραφηθούν σε αδύναμες οικονομικά και κοινωνικά ομάδες. Συμπερασματικά θα μπορούσαμε να πούμε πως οι Έλληνες γιατροί εξακολουθούν να εμπιστεύονται τόσο τα πρωτότυπα φάρμακα που προστατεύονται με πατέντα, όσο και τα πρωτότυπα εκτός πατέντας φαρμακευτικά σκευάσματα (σκευάσματα δηλαδή τα οποία αν και κυκλοφόρησαν ως πρωτότυπα έχουν απολέσει την προστασία της πατέντας τους). Παρόλο όμως που θεωρούν τα προαναφερθέντα φάρμακα αποτελεσματικά και αξιόπιστα, μια σειρά από εξωτερικούς παράγοντες τους δημιουργεί την τάση να κινηθούν προς την κατεύθυνση των γενοσήμων, περισσότερο από ότι στο πρόσφατο παρελθόν. / Today science promises new discoveries that will allow us to live not only longer but also better. The pharmaceutical industry plays a leading role to this fact where through continuous research and development, new, innovative, brand named drugs are produced. Brand named drugs continue to hold the leading place in the global pharmaceutical market, although after the expiration of their patent they face severe pressure from the production of their counterparts, generic drugs. It is essential to emphasize the important role that brand named drugs have to the protection of the public health, even though at the same time many unknown generic drugs have entered the Greek pharmaceutical market under the justification of the financial crisis and the containment of pharmaceutical expenditures. Under this prism, the present thesis tries to determine the reasons and the motivations of Greek physicians for prescribing brand names drugs, within a turbulent and constantly changing external environment. Our basic purpose was to discover the factors that make the physicians prescribebrand named drugs and how these factors were related with a number of external factors. The findings of this thesis are derived from the answers given by 83 doctors of different specialties. The specialties were those that have high prescription capability, with pathologists and orthopedics being the two most numerous specialties. The research was conducted with the participation of doctors from the counties of Achaia, Ilia and Cephalonia. The most important findings that came up after the statistical analysis of the answers given were: 1) The great acceptance that brand named drugs still have from the Greek medical community, even when their counterpart generics exist in the market 2) The main factors that influence the doctors prescriptions are: a) the efficacy of the medicine b) the prestige / name of the pharmaceutical company c) the price of the medicine d) the innovation of the medicine e) the safety / side effects 3) The pharmaceutical companies that produce brand named drugs influence the doctors prescriptions by their prestige and good name 4) The financial crisis in Greece and the measures that have been taken by the state for reducing the pharmaceutical expenditures seem to influence some doctors to prescribe more generics than they did in the past 5) “Opinion leaders” influence the prescription attitude of the Greek doctors only when they appear to congresses and forums as “independent” scientists. On the other hand they seem not to influence at all when they appear as speakers to any corporate event sponsored by a pharmaceutical company 6) Marketing practices of companies producing brand named drugs seem to be more effective than those that produce generic drugs 7) A medical representative that is well educated about his drug positively influences the prescription habits of the doctors 8) It is observed a tendency of doctors for taking low risk when they prescribe madicines to their patients 9) Generic drugs are more likely to be prescribed to low income and low social status groups of the population. In conclusion we can say that Greek doctors still trust not only the brand named drugs protected under patent, but also the off patent brand name drugs (brand named drugs that their patent has expired). Although they consider the aferementioned drugs effective and reliable, a number of external factors create a tendency for them to prescribe now more generic drugs than they used to prescribe in the recent past.

Στην Ελλάδα ο όρος “γενόσημα” φάρμακα έχει γίνει ευρέως γνωστός τον τελευταίο καιρό, παρ’ό,τι στην Ευρώπη και σε άλλες χώρες του κόσμου η χρήση γενοσήμων είναι γνωστή εδώ και δεκαετίες. Η παρούσα διπλωματική εργασία έχει σκοπό να μελετήσει τους παράγοντες που επηρεάζουν τη στάση ασθενών-καταναλωτών και επαγγελματιών υγείας ως προς τα γενόσημα φάρμακα. Πιο συγκεκριμένα, μελετώνται διάφοροι παράγοντες που βρέθηκαν μέσα από τη βιβλιογραφική ανασκόπηση ότι επηρεάζουν τις πεποιθήσεις των ασθενών-καταναλωτών και των επαγγελματιών υγείας. Αρχικά, έγινε μια βιβλιογραφική ανασκόπηση σε μελέτες της διεθνούς βιβλιογραφίας σχετικά με το θέμα των γενόσημων φαρμάκων. Στη συνέχεια, κατασκευάστηκαν δύο ερωτηματολόγια, ένα που απευθυνόταν σε ασθενείς-καταναλωτές και ένα που απευθυνόταν σε επαγγελματίες υγείας. Το πρώτο ερωτηματολόγιο συμπλήρωσαν 364 ασθενείς-καταναλωτές. Το δεύτερο συμπλήρωσαν 95 επαγγελματίες υγείας (ιατροί και φαρμακοποιοί). Τα στοιχεία που συλλέχθηκαν από τα ερωτηματολόγια αναλύθηκαν στη συνέχεια με τη βοήθεια του προγράμματος SPSS. Από τις αναλύσεις που έγιναν, διαπιστώσαμε πως στους περισσότερους πλέον ασθενείς ο όρος «γενόσημα φάρμακα» είναι γνώριμος αλλά, υπάρχει έλλειψη σωστής πληροφόρησης. Παρόλα αυτά, οι μισοί σχεδόν ασθενείς έχουν θετική στάση προς τα γενόσημα φάρμακα και είναι διατεθειμένοι να τα χρησιμοποιήσουν μετά από σύσταση του ιατρού κυρίως, ή και του φαρμακοποιού. Επίσης, οι πιο σημαντικοί λόγοι που τους ωθούν να αγοράσουν ένα φάρμακο είναι η ασφάλεια και η αποτελεσματικότητά του. Από τις αναλύσεις των απαντήσεων των επαγγελματιών υγείας διαπιστώσαμε πως υπάρχει έλλειψη γνώσεων και σωστής πληροφόρησης. Ενώ είναι πρόθυμοι να συνταγογραφήσουν/χορηγήσουν γενόσημα φάρμακα, παρόλα αυτά, προτιμάται η χρήση πρωτότυπων φαρμακευτικών σκευασμάτων, πιθανότατα λόγω της έλλειψης εμπιστοσύνης προς τον ΕΟΦ. Πιστεύεται πως η βελτίωση της αξιοπιστίας του Οργανισμού και η καλύτερη ενημέρωση των επαγγελματιών υγείας θα συμβάλει στην αύξηση χρήσης των γενοσήμων. Το κράτος έχει θεσπίσει ήδη αρκετά μέτρα για την αύξηση χρήσης των γενοσήμων. Προτείνεται όμως, να γίνει μια πιο ολοκληρωμένη προσπάθεια μέσα από τα κανάλια των επαγγελματιών υγείας, της φαρμακευτικής βιομηχανίας αλλά και των ασθενών-καταναλωτών, ώστε να αποδώσει η προσπάθεια αυτή και επιτευχθεί ο σκοπός της. / In Greece the term "generic" drugs has become widely known lately, although in Europe and other countries of the world, generics are known for decades. This thesis aims to study the factors that affect the attitude of patients-consumers and health professionals to generics. More specifically, it examines various factors found through the literature to influence the beliefs of patients, consumers and healthcare professionals. Initially, there was a literature review on studies of the literature on the subject of generic drugs. Then, we constructed two questionnaires, one aimed at patients-consumers and one that was aimed at health professionals. The first questionnaire was completed by 364 patient-consumers. The second was completed by 95 health professionals (doctors and pharmacists). The data collected from the questionnaires were then analyzed using the SPSS program. From the analyzes, we found that among most patients the term "generic" is familiar, but there is a lack of proper information. However, almost half patients have positive attitude towards generics and are willing to use them with the recommendation of a physician primarily, or a pharmacist. Also, the most important reasons that make them buy a drug is knowing it’s safe and effective. The analyzes of the responses of health professionals found that there is lack of knowledge and correct information among them. While they are willing to prescribe/dispense generics, however, original drugs are preferred, probably due to lack of confidence in the regional EMEA. According to them, improvement of the reliability of the Agency and better information of the health professionals will help increase the use of generics. The state has already adopted several measures to increase the use of generics. But it is proposed that a more integrated effort, through the channels of health professionals, pharmaceutical industry and patients and consumers should take place so that to this effort and purpose are achieved.