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

No description available.

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).

Physicians often continue to prescribe brand-name drugs to their patients even when less expensive generic equivalents are available. In a 1994 study, Judith Hellerstein advances two hypotheses to explain this behavior. First, doctors may consciously conclude that certain brand-name drugs impart a relative therapeutic benefit that outweighs their higher cost. Second, physicians may choose to prescribe brand-name drugs without evidence of therapeutic superiority if neither they nor their insured patients bear the increased cost of these drugs. The second hypothesis implies that moral hazard is evident in physicians' prescribing behavior. Hellerstein's findings support neither hypothesis, but her estimation equation does not explicitly capture the effects of brand-name/generic price differentials and information diffusion on the probability of generic prescription. The author adapts Hellerstein's theoretical model to a modified estimation equation that incorporates these effects and uses it to create new estimates based on data on antimicrobial prescriptions from the 1994 National Ambulatory Medical Care Survey (NAMCS). Unexpectedly, the results appear to affirm both hypotheses. The evidence for moral hazard is particularly strong, as self-paying patients are significantly more likely than patients with Medicare or private insurance to be prescribed the generics that are cheapest relative to their brand-name counterparts. The author also finds that certain popular antimicrobial drugs such as amoxicillin and sulfamethoxazole/trimethoprim are prescribed in the same form (generic or brand-name) by most doctors to most patients. The market power exhibited by these preferred forms leads the author to conclude that they are "brands" in the economic sense. / Master of Arts