People increasingly face the choice of branded or generic medicines and the decision sometimes is a difficult one. This research work was designed to determine the perceived benefits of generic versus branded medicines. People’s perception of things, does affect their choices. It is almost a decade since generics were introduced to the healthcare system in South Africa and very few studies have been done to access whether the idea of having generic medicines is working. A survey was carried out and the results were analysed using a logistic regression. The results showed that females knew more about generic medicines than males. The variables of cost, safety and quality of medicines still remain a determining factor for the purchase of medicines either generic or branded. In addition, people’s income was seen to influence the type of medicines that they buy. It was seen that there was a direct relationship between the income of respondents and their preferences when it came to the purchase of medicine. Access to medical aid was confirmed to predispose people to opt for branded medicine against the cheaper generics since they are not paying directly. / Dissertation (MBA)--University of Pretoria, 2010. / Gordon Institute of Business Science (GIBS) / unrestricted

Masters of Public Health - see Magister Public Health / Overreliance on donor supported health programs has crippled many African countries and there is inadequate long-term planning on the future sustainability of health systems. In the age of uncertainty in global politics and global economy, the future of these donor funded programs is also uncertain. It is imperative for African nations to begin to take responsibility for their health programs. In as much as the name “donation” suggests that something is given free of charge, in actual sense this may not be the case due to hidden costs attached. In medicine access, the hidden costs are the supply chain costs including cost for clearance, storage and distribution of such medicines which are charged as a percentage of claimed commodity costs on donors’ or suppliers’ invoices. Since the medicines donated are in originators’ brands, the invoiced prices are high thus supply chain costs are high as well. In some cases, it is thought that the hidden costs are higher than the cost of medicines had they been sourced locally as generics. The aim of this research was to assess and determine the hidden supply chain costs associated with the four medicine donation programs supporting the Tanzania Neglected Tropical Diseases Program and inform policy decision on optimal financing options for the program Methodology The cost analysis of the two options was undertaken from a payers’ perspective which in this case is the Government of Tanzania (Ministry of Health). Data was collected on both product and supply chain cost drivers incurred in the medicine donation programs from July 2014 to June 2017. Costs of the current mechanism were obtained from the program’s quantification reports and transaction data for the study period. Transactional data was obtained from shipment documents including sales invoices, parking list, proof of delivery and goods receiving notes were evaluated for actual quantities shipped, commodity prices and other supply chain cost. To verify the actual supply chain cost charged by the program, both the official bills from Medical Stores Department (MSD) to the program and the electronic bills available at MSD electronic database covering the study period were studied.

Magister Public Health - MPH / Background: South African medical scheme members needlessly purchase high cost originator prescription medicines which attract out of pocket co-payments at pharmacies. This is despite availability of low priced generic medicines that are paid for in full by medical schemes. Co-payments result from misalignment between prices of the dispensed medicine and that of the alternative medicine which appears on the medical scheme's formulary list and for which the scheme is prepared to pay for in full. To establish what factors caused such misalignment, perspectives of medical scheme members and key informants which included pharmacists, regulators and representatives of medical schemes were explored. The study focused on co-payments for prescription medicines dispensed at private sector retail pharmacies in Pretoria, South Africa. Aim: The aim of the study was to explore views about co-payments and identify factors that motivate and influence Pretoria medical scheme members to co-pay when purchasing prescription medicines at pharmacies, despite being insured by medical scheme insurance organizations. Methodology: An exploratory qualitative research study was performed. Semi-structured interviews were conducted among purposefully selected medical scheme members (12) and 9 key informants. Key informants consisted of dispensing pharmacists (6), regulators of health professionals and medical schemes (2) and a senior official (1) with experience in the regulation of medicines and operations within medical scheme organizations. From a total of twelve interviewed medical scheme members, eight were interviewed at preselected retail pharmacies after they had made a co-payment and the other four selected because they did not make a co-payment. To ensure diversity in views about co-payments and related factors, dispensing pharmacists, co-paying and non co-paying medical scheme members were accessed from six pharmacies that are located in two separate locations of different socioeconomic status in Pretoria, that is, the Pretoria East suburban area and Pretoria city centre which is close to Pretoria central station and taxi routes. Three pharmacies were identified from each of the two different geographical locations, one independent and two corporate pharmacies per socioeconomic area. One pharmacist was interviewed from each of the selected pharmacies and medical scheme members were accessed from across the six pharmacies. The remainder of the key informants such as the regulators, were interviewed during office hours at venues of their choice which included areas of work. A pilot study was conducted among medical scheme members and pharmacists to test the applicability of interview tools. All interviews were conducted face-to-face by the researcher and recorded. The electronic record was independently compared with the researcher's enhanced notes for data accuracy. Codes identified during data analysis were derived from the interview notes and recordings and translated into organized text for theme development in a manner that referenced them to each study objective. Themes were arrived at after combining similar codes which were noted as representing a particular description for use during data interpretation and report writing. Ethics: Ethical clearance was sought from the UWC Senate Research Committee and granted. Prior to conducting interviews, written consent was obtained from all participants. Research details were explained and also provided on the participant information sheet wherein voluntary participation was emphasized. Anonymity and confidentiality was maintained throughout. Results: All patients and pharmacists expressed confusion about the medical scheme rules and related co-payments. There were differing co-payment perspectives among scheme members depending on socioeconomic status, with affordability being a key factor among those of lower socio-economic status whilst convenience and lack of comprehensible information about co-payments was prioritised amongst those members of higher socioeconomic status. Key influences on patient's purchasing decisions were health professionals (both doctors and pharmacists), with friends, family members and advertisements less influential. Patients and medical schemes generally preferred to utilise large chain pharmacies and patients, in particular, had a poor perception of the quality of generics. In general, the first prescribed medicine was highly favoured by patients and this influenced medicine preferences during subsequent prescriptions, especially for non communicable disease (NCD) medicines. Pharmacists did not apply the generic substitution policy in a manner that benefited the consumer because the lowest priced generic was frequently not kept as pharmacy stock. Co-payments appeared to create a divide between corporate and independent pharmacies. Some regulators tended to blame patients, pharmacists and medical schemes rather than the lack of adequate enforcement of national policies and regulations. Inadequate monitoring and enforcement of pro-consumer policies were found to be the main factors that contributed to co-payments. Conclusions and Recommendations: The introduction of regulations on minimum requirements for stock available at private sector retail pharmacies should be considered to ensure availability of the lowest priced generic at all times. This would ensure that co-payments are reduced and the desired consumer benefits that should accrue from the existing generic substitution policy are realized and maximized. To prevent perception-based and self-initiated co-payment behavior among consumers, vigorous and continued education about the value and equivalence of generics should be championed at the highest level of government with the execution of this critical responsibility not left to those with profit driven motives. Consumers might benefit from extensive education about the purchasing choices made at pharmacies and, in particular, the negative financial consequences associated with choosing a preferred but highly priced originator versus a low cost generic medicine which is used to treat the same ailment. Enforcement of policies by dedicated government agencies could further protect consumers from preventable high cost of healthcare and of medicines in particular.

No abstract available / Dissertation (LLM)--University of Pretoria, 2012. / gm2014 / Centre for Human Rights / Unrestricted

A Política de Saúde no Brasil, que inclui a Política Nacional de Medicamentos, a criação da Agência Nacional de Vigilância Sanitária (ANVISA), a promulgação da Lei de Medicamentos Genéricos, bem como a publicação das Resoluções que estabelecem os critérios técnicos para seu registro, revolucionou o mercado farmacêutico brasileiro na última década, introduzindo vários conceitos como Equivalência Farmacêutica e Terapêutica, Biodisponibilidade e Bioequivalência. Tais conceitos constituem as bases científicas para a implantação dos medicamentos genéricos, aliados à certificação de Boas Práticas de Fabricação e Controle de Qualidade (BPFs). Após cinco anos, os medicamentos genéricos representam cerca de 10% do mercado farmacêutico brasileiro em unidades com redução mínima de 35% no preço do genérico em relação ao medicamento de referência, em função de que o fabricante não necessita investir em estudos clínicos para comprovação da eficácia e segurança, garantidas pela comprovação da equivalência terapêutica com o medicamento de referência. O mercado brasileiro de genéricos é muito atrativo, pois 86% dos fármacos registrados no país não são patenteados e mais de 50% da população brasileira não tem acesso a medicamentos por problemas econômicos. Por outro lado, 70% do mercado farmacêutico brasileiro é composto por medicamentos similares, que somente em 2003 passaram a ter regulamentação técnica específica para comprovação da eficácia e segurança. Dessa forma, apesar de vasta literatura existente, justifica-se a sistematização dos aspectos técnicos e científicos que fundamentam a regulamentação técnica de biodisponibilidade relativa e bioequivalência com aplicabilidade na XXIII capacitação de recursos humanos em Biofarmacotécnica e na área regulatória no país. A análise da implantação e evolução das regulamentações técnicas, bem como, das conclusões dos estudos de bioequivalência e biodisponibilidade relativa avaliados pela ANVISA, torna-se ferramenta essencial para a compreensão dos aspectos regulatórios dos estudos de biodisponibilidade relativa e bioequivalência adotados. Considerando-se, ainda, a importância da racionalização de recursos e a necessidade de manutenção da qualidade dos medicamentos genéricos e similares no Brasil, com base na literatura científica mundial e no Banco de Dados da ANVISA, avaliou-se a viabilidade do emprego do Sistema de Classificação Biofarmacêutica (SCB), proposta elaborada por Amidon et al. (1995), para isenção da necessidade de realização de estudos de biodisponibilidade relativa/bioequivalência para o registro e pós-registro de medicamentos no Brasil. Assim sendo, concluiu-se que: a implantação de medicamentos genéricos no Brasil significou grande avanço técnico-científico para as áreas regulatória, acadêmica e industrial; a implementação e o aprimoramento da regulamentação técnica para medicamentos genéricos ocorreu devido à sua revisão contínua e publicação de quatro novas versões no período de 2.000 a 2.004; a experiência adquirida foi a base para a elaboração da regulamentação para medicamentos similares; a reprovação de estudos de bioequivalência de fármacos da Classe I do SCB é um alerta para que um estudo aprofundado das causas e da aplicação desse sistema na isenção de estudos in vivo visando o registro de medicamentos no Brasil seja realizado. / Health Policy in Brazil, which includes the National Policy on Medicines, the creation of the National Agency for Sanitary Vigilance (ANVISA), the promulgation of the Generic Medicines Law, as well as the publication of Resolutions establishing technical criteria for their registration, has revolutionized the Brazilian pharmaceutical market over the past decade introducing a number of concepts such as Pharmaceutical and Therapeutic Equivalence, Bioavailability and Bioequivalence. Such concepts have comprised the scientific basis for the implementation of generic medicines, in conjunction with the certification of Good Manufacturing and Quality Control Practices (BPFs). Five years on, generic medicines account for around 10% of the Brazilian pharmaceutical market in units, with a price cut in generics of at least 35% compared with the corresponding reference medicine, as a result of manufacturers not having to invest in clinical trials to prove efficacy and safety which are guaranteed by proof of therapeutic equivalence to the reference medicine. The Brazilian generics market is highly attractive since 86% of active principles registered in the country are not patented, and given that more than 50% of the Brazilian population does not have access to medicines for economic reasons. However, 70% of the Brazilian pharmaceutical market is made up of similar medicines, which only gained specific technical regulation for proof of efficacy and safety in 2003. Therefore, despite the vast body of literature available, a systematic approach for technical and scientific aspects underlying the technical regulation of relative bioavailability and bioequivalence is warranted, where this may also apply to both training of human resources in Biopharmaceutics and to the regulatory area in the country. Analysis of the XXVI implementation and evolution of technical regulations, along with the conclusions of ANVISA-assessed bioequivalence and relative bioavailability trials, have become an essential tool in understanding the regulatory aspects of the studies on relative bioavailability and bioequivalence adopted. Furthermore, given the continuing importance of rationalizing resources and the need to maintain the quality of generic medicines and similars in Brazil, the viability of employing the Biopharmaceutical Classification System (SCB) proposed by Amidon et al. (1995) dispensing with the need to run relative bioavailability/bioequivalence studies for the registration and post-registration of medicines in Brazil, has been assessed based on world scientific literature and ANVISAs database. Thus it was concluded that the implementation of generic medicines in Brazil has represented a major technical and scientific step forward for the regulatory, academic and industrial areas. Moreover, the implementation and refining of the technical regulations for generic medicines has taken place as a result of ongoing review and publication of four new versions between 2000 and 2004. The experience gained has provided the foundation in devising technical regulations for similar medicines. Finally, the rejection of bioequivalence studies for medicines from Class 1 SCB may serve as a warning that more in-depth studies into the root causes, and the application of this system in the absence of in-vivo studies for registration of medicines in Brazil, should be undertaken.

A Política de Saúde no Brasil, que inclui a Política Nacional de Medicamentos, a criação da Agência Nacional de Vigilância Sanitária (ANVISA), a promulgação da Lei de Medicamentos Genéricos, bem como a publicação das Resoluções que estabelecem os critérios técnicos para seu registro, revolucionou o mercado farmacêutico brasileiro na última década, introduzindo vários conceitos como Equivalência Farmacêutica e Terapêutica, Biodisponibilidade e Bioequivalência. Tais conceitos constituem as bases científicas para a implantação dos medicamentos genéricos, aliados à certificação de Boas Práticas de Fabricação e Controle de Qualidade (BPFs). Após cinco anos, os medicamentos genéricos representam cerca de 10% do mercado farmacêutico brasileiro em unidades com redução mínima de 35% no preço do genérico em relação ao medicamento de referência, em função de que o fabricante não necessita investir em estudos clínicos para comprovação da eficácia e segurança, garantidas pela comprovação da equivalência terapêutica com o medicamento de referência. O mercado brasileiro de genéricos é muito atrativo, pois 86% dos fármacos registrados no país não são patenteados e mais de 50% da população brasileira não tem acesso a medicamentos por problemas econômicos. Por outro lado, 70% do mercado farmacêutico brasileiro é composto por medicamentos similares, que somente em 2003 passaram a ter regulamentação técnica específica para comprovação da eficácia e segurança. Dessa forma, apesar de vasta literatura existente, justifica-se a sistematização dos aspectos técnicos e científicos que fundamentam a regulamentação técnica de biodisponibilidade relativa e bioequivalência com aplicabilidade na XXIII capacitação de recursos humanos em Biofarmacotécnica e na área regulatória no país. A análise da implantação e evolução das regulamentações técnicas, bem como, das conclusões dos estudos de bioequivalência e biodisponibilidade relativa avaliados pela ANVISA, torna-se ferramenta essencial para a compreensão dos aspectos regulatórios dos estudos de biodisponibilidade relativa e bioequivalência adotados. Considerando-se, ainda, a importância da racionalização de recursos e a necessidade de manutenção da qualidade dos medicamentos genéricos e similares no Brasil, com base na literatura científica mundial e no Banco de Dados da ANVISA, avaliou-se a viabilidade do emprego do Sistema de Classificação Biofarmacêutica (SCB), proposta elaborada por Amidon et al. (1995), para isenção da necessidade de realização de estudos de biodisponibilidade relativa/bioequivalência para o registro e pós-registro de medicamentos no Brasil. Assim sendo, concluiu-se que: a implantação de medicamentos genéricos no Brasil significou grande avanço técnico-científico para as áreas regulatória, acadêmica e industrial; a implementação e o aprimoramento da regulamentação técnica para medicamentos genéricos ocorreu devido à sua revisão contínua e publicação de quatro novas versões no período de 2.000 a 2.004; a experiência adquirida foi a base para a elaboração da regulamentação para medicamentos similares; a reprovação de estudos de bioequivalência de fármacos da Classe I do SCB é um alerta para que um estudo aprofundado das causas e da aplicação desse sistema na isenção de estudos in vivo visando o registro de medicamentos no Brasil seja realizado. / Health Policy in Brazil, which includes the National Policy on Medicines, the creation of the National Agency for Sanitary Vigilance (ANVISA), the promulgation of the Generic Medicines Law, as well as the publication of Resolutions establishing technical criteria for their registration, has revolutionized the Brazilian pharmaceutical market over the past decade introducing a number of concepts such as Pharmaceutical and Therapeutic Equivalence, Bioavailability and Bioequivalence. Such concepts have comprised the scientific basis for the implementation of generic medicines, in conjunction with the certification of Good Manufacturing and Quality Control Practices (BPFs). Five years on, generic medicines account for around 10% of the Brazilian pharmaceutical market in units, with a price cut in generics of at least 35% compared with the corresponding reference medicine, as a result of manufacturers not having to invest in clinical trials to prove efficacy and safety which are guaranteed by proof of therapeutic equivalence to the reference medicine. The Brazilian generics market is highly attractive since 86% of active principles registered in the country are not patented, and given that more than 50% of the Brazilian population does not have access to medicines for economic reasons. However, 70% of the Brazilian pharmaceutical market is made up of similar medicines, which only gained specific technical regulation for proof of efficacy and safety in 2003. Therefore, despite the vast body of literature available, a systematic approach for technical and scientific aspects underlying the technical regulation of relative bioavailability and bioequivalence is warranted, where this may also apply to both training of human resources in Biopharmaceutics and to the regulatory area in the country. Analysis of the XXVI implementation and evolution of technical regulations, along with the conclusions of ANVISA-assessed bioequivalence and relative bioavailability trials, have become an essential tool in understanding the regulatory aspects of the studies on relative bioavailability and bioequivalence adopted. Furthermore, given the continuing importance of rationalizing resources and the need to maintain the quality of generic medicines and similars in Brazil, the viability of employing the Biopharmaceutical Classification System (SCB) proposed by Amidon et al. (1995) dispensing with the need to run relative bioavailability/bioequivalence studies for the registration and post-registration of medicines in Brazil, has been assessed based on world scientific literature and ANVISAs database. Thus it was concluded that the implementation of generic medicines in Brazil has represented a major technical and scientific step forward for the regulatory, academic and industrial areas. Moreover, the implementation and refining of the technical regulations for generic medicines has taken place as a result of ongoing review and publication of four new versions between 2000 and 2004. The experience gained has provided the foundation in devising technical regulations for similar medicines. Finally, the rejection of bioequivalence studies for medicines from Class 1 SCB may serve as a warning that more in-depth studies into the root causes, and the application of this system in the absence of in-vivo studies for registration of medicines in Brazil, should be undertaken.

Αποτελεί αδιαμφισβήτητο γεγονός ότι τις τελευταίες δεκαετίες η βιομηχανία γενόσημων φαρμάκων σημειώνει παγκοσμίως σημαντική πρόοδο και ανάπτυξη. Η εκτεταμένη διείσδυση των γενόσημων φαρμάκων στο χώρο της υγείας δεν είναι καθόλου τυχαία και οφείλεται κατά κύριο λόγο στην οικονομική και αξιόπιστη θεραπευτική λύση που προσφέρουν. Με άλλα λόγια το πλεονέκτημά τους είναι ότι επιφέρουν ισότιμο θεραπευτικό αποτέλεσμα, όπως και τα πρωτότυπα φάρμακα, σε συνδυασμό με τον περιορισμό των φαρμακευτικών δαπανών. Η ιδιαιτερότητά τους αυτή καθορίζεται και εξασφαλίζεται μέσω του ελέγχου της βιοϊσοδυναμίας τους και της χρονικής λήξης των διπλωμάτων ευρεσιτεχνίας των πρωτότυπων φαρμάκων. Από τα παραπάνω λοιπόν, σε συνδυασμό με τη δυσμενή παγκόσμια οικονομική κατάσταση και με τα διογκωμένα οικονομικά προβλήματα που ταλανίζουν το ελληνικό σύστημα υγείας και τους εθνικούς ασφαλιστικούς οργανισμούς, καταδεικνύεται η ανάγκη ευρείας αποδοχής των συγκεκριμένων φαρμάκων από το σύνολο της ελληνικής ιατρικής κοινότητας. Για το σκοπό αυτό η συγκεκριμένη διπλωματική εργασία επιδιώκει να διερευνήσει σε βάθος τις πεποιθήσεις, τα κίνητρα και τις συνταγογραφικές συνήθειες των Ελλήνων ιατρών όσον αφορά τα γενόσημα φάρμακα, τα οποία υπόσχονται τον άμεσο περιορισμό των φαρμακευτικών δαπανών χωρίς την υποβάθμιση της ωφέλειας και της ποιότητας ζωής των ασθενών. Τα ευρήματα που προέκυψαν από την έρευνα που διεξήχθη αποκλειστικά στο Νόμο Αχαΐας είναι σημαντικά και αναλύονται διεξοδικά παρακάτω. Παρολ’ αυτά σε γενικές γραμμές αξίζει να αναφερθεί: α) το υψηλό ποσοστό απόκρισης 75,7% στη συμπλήρωση του ερωτηματολογίου, β) το υψηλό ποσοστό μετεκπαίδευσης των ιατρών που ανέρχεται στο 41.6%, γ) η εξοικείωση των ιατρών με τις νέες τεχνολογίες και το διαδίκτυο που φτάνει το 55.7%, δ) ότι το σύνολο των ιατρών συνταγογραφεί γενόσημα φάρμακα ανεξαρτήτως εάν έχουν θετική γνώμη για αυτά ή όχι, ε) ότι το πρωταρχικό και βασικότερο κριτήριο συνταγογράφησης είναι η αποτελεσματικότητα του φαρμάκου, ενώ και τα οικονομικά κίνητρα συμβάλλουν σε πολύ μεγάλο βαθμό προς την κατεύθυνση αυτή, στ) ότι η απουσία κλινικών δοκιμών των γενόσημων φαρμάκων αποτελεί το σημαντικότερο παράγοντα υστέρησης συγκριτικά με τα πρωτότυπα φάρμακα, ζ) ότι υπάρχουν δευτερογενείς παράγοντες που μπορούν να συμβάλλουν στην αυξημένη συνταγογράφηση των γενόσημων φαρμάκων π.χ. κύρος-όνομα εταιρείας, η επιστημονική ενημέρωση κ.ά., η) ότι οι συνταγογραφικές συνήθειες των ιατρών επηρεάζονται σε μικρό βαθμό από τους ιατρικούς επισκέπτες και σε μεγάλο βαθμό από το όνομα και το κύρος της φαρμακευτικής εταιρείας και θ) ότι δεν εισακούγονται σε μεγάλο ποσοστό 58.5% οι ανάγκες και οι προβληματισμοί των ιατρών από τα φαρμακευτικά στελέχη. Η παρούσα εργασία με τις συγκεκριμένες εστιάσεις προσπαθεί να αποκρυπτογραφήσει τη στάση και τους πιθανούς προβληματισμούς των ελλήνων ιατρών σχετικά με τα γενόσημα φάρμακα και να προσδιορίσει τη συνταγογραφική συμπεριφορά αυτών. Απώτερος σκοπός του παραπάνω εγχειρήματος είναι να βοηθήσει από τη μεριά του στην ανάπτυξη και στη χάραξη πολιτικών και κατευθύνσεων που να είναι σε θέση να βελτιώσουν την οικονομική και κλινική εικόνα του πολύπαθου χώρου της ελληνικής δημόσιας υγείας. / Is it an undeniable fact that in the last decades the manufacture of generic medicinal products marks globally significant progress and development. The vast permeation of generic medicinal products in the health industry is not random at all and is mainly due to the economical and reliable therapeutic solution they offer. In other words, their advantage lies in the fact that they bring equivalent therapeutic results to the reference medicinal products, combined with a reduction of medicinal expenses. This specificity of theirs is determined and secured through the control of their bioequivalence and the expiration time of the letters patent of the reference medicinal products. From all the above and taking into consideration the unfavorable global economic situation and the inflated economic problems which deplore the greek health system and the national insurance organizations, rises the need for a vast acceptance of these particular medicinal products from the greek medical community in its entirety. For this reason, this particular thesis attempts to explore in depth the greek physicians’ beliefs, motives and prescription-writing practices as far as generic medicinal products are concerned – which promise the immediate reduction of medicinal expenses without downgrading the patients’ benefits and quality of living. The findings that emerged from the research which was carried out exclusively within the prefecture of Achaia are significant and are analysed in depth further below. Nevertheless, in general, it is worth mentioning: a) the high rate of responding (75.7%) to the completion of the questionnaire, b) the high rate of doctors’ further education/training which reaches 41.6% c) the doctors’ familiarization with new technologies and the internet which comes to 55.7%, d) the fact that the doctors as a body are prescribing generic medicinal products regardless of their positive or negative views on them, e) that the prime and most fundamental criterion in prescription-writing is the effectiveness of the drug, while economic motives contribute greatly towards this direction, f) that the absence of clinical tests on generic medicinal products is the most significant factor of their lacking in comparison to reference medicinal products, g) that there are secondary factors which can contribute to the increase in prescription of generic medicinal products such as the prestige/brand name of a company, scientific documentation, etc. h) that the physicians’ prescription habits are minorly affected from pharmaceutical representatives and majorly from the brand name and prestige of the pharmaceutical company and i) that in a high rate of 58.5% physicians’ needs and problems are not heard from pharmaceutical executives. This thesis with its particular focuses, attempts to decode greek physicians’ views and possible problems as far as general medicinal products are concerned and to define their attitude towards prescription. A further goal of this attempt is to help the development and tracing of political directions which can be able to improve the economic and clinical image of the much afflicted greek national health system.

Conselho Nacional de Desenvolvimento CientÃfico e TecnolÃgico / A consolidaÃÃo do mercado de medicamentos genÃricos no Brasil representa importante estratÃgia governamental, uma vez que significarà maior acesso da populaÃÃo aos medicamentos. A Lei n 9.787, de 10 de fevereiro de 1999, estabeleceu as bases legais para a instituiÃÃo do medicamento genÃrico no PaÃs. Os laboratÃrios de equivalÃncia farmacÃutica fazem a verificaÃÃo entre dois medicamentos que contÃm a mesma molÃcula terapeuticamente ativa, na mesma quantidade e forma farmacÃutica, podendo ou nÃo conter excipientes idÃnticos, se sÃo equivalentes in vitro. Os Centros de EquivalÃncia FarmacÃutica devem ser habilitados pela ANVISA, isto Ã, devem ser inspecionados pela GerÃncia-Geral de LaboratÃrio de SaÃde PÃblica (GGLAS), passando a fazer parte da Rede Brasileira de LaboratÃrios AnalÃticos em SaÃde (REBLAS) e apartir de entÃo, autorizados para a realizaÃÃo dos estudos de equivalÃncia farmacÃutica. Neste contexto foi implantado o LaboratÃrio de EquivalÃncia FarmacÃutica da Unidade de Farmacologia ClÃnica seguindo a seguinte metodologia: adequaÃÃo da infra-estrutura fÃsica do laboratÃrio; qualificaÃÃo e calibraÃÃo de aparelhos/equipamentos; validaÃÃo de MÃtodos AnalÃticos; preparaÃÃo dos Procedimentos Operacionais PadrÃo (POP) e implantaÃÃo do Sistema da Qualidade (SQ); realizaÃÃo de um ensaio piloto de EquivalÃncia FarmacÃutica. Um estudo piloto de equivalÃncia farmacÃutica foi realizado e utilizou-se para isso o medicamento Oxcarbazepina onde foram analisados os seguintes parÃmetros: Dureza, DesintegraÃÃo, IdentificaÃÃo, DissoluÃÃo e Perfil de dissoluÃÃo obtendo resultados favorÃveis em todos os testes. Conclui-se entÃo serem equivalentes farmacÃuticos os medicamentos teste e referÃncia analisados demonstrando que o laboratÃrio encontra-se apto para realizar as anÃlises a que se destina. No dia 22/06/2004 foi entÃo habilitado pela ANVISA recebendo o nÃmero EQFAR 047 / The consolidation of the generic medicine market in Brazil represents important governmental strategy, a time that will mean greater access of the population to medicines. The Law n 9,787, of 10 of February of 1999, it established the legal bases for the institution of the generic medicine in the Country. The laboratories equivalence pharmaceutical make the verification between two medicines that the same therapeutically active molecule contains, in the same amount and pharmaceutical form, being able or not to contain identical excipient, if vitro is equivalents in. The Centers of Equivalence Pharmaceutical must be qualified visor ANVISA, that is, they are evaluated by General Office of Laboratories of Public Health (GGLAS), second determined parameters, starting to be part of Brazilian Net of Analytical Laboratories in health (REBLAS) and being, from now on, authorized for the accomplishment of the studies equivalence pharmaceutical. (In this context it is that the following methodology was implemented the Pharmaceutical equivalence Laboratory of the UNIFAC having followed: Physical infrastructure and adequacy of the laboratory; Qualification and calibration of devices equipment; Validation of Analytical Methods; Preparation of Operational Procedures Standard (POP) and Implantation of the System of Quality (SQ); Accomplishment of a Pharmaceutical assay equivalence Pilot; Having been approved qualified for the ANVISA in day 22/06/2004. For the study pilot the Oxcarbazepine medicine was used for the pharmaceutical equivalence pilot and had been analyzed the following parameters: Hardness, Disintegration, Identification, Dissolution and Profile of dissolution getting resulted favorable in all the tests. It is concluded then to be pharmaceutical equivalents the analyzed medicines has tested and reference demonstrating that the laboratory meets apt to carry through the analyses the one that if destines

Magister Legum - LLM / Access to medicines is an essential component of the basic human right to health and a key determinant of the importance attached to the health care system of a country. It essentially entails the availability and acceptability of the essential medicines on the market and the ability of patients to afford such medicines when needed. Globally, countries face access to medicine challenges partly because of patents which undoubtedly accounts for excessive pricing of medicine. As such, efforts have been made to ensure the accessibility of medicines through the Trade-Related Aspect of Intellectual Property Rights (TRIPS) flexibilities of the World Trade Organisation (WTO). Beyond these interventions, it is incumbent on Members of the WTO to domesticate the flexibilities of the TRIPS Agreement before their utilisation because by their very nature, they cannot be self-executed. With an estimated population of 29.6 million, about 310 000 people in Ghana are living with HIV. The country’s health facilities record 40 per cent of outpatient visits each year and about 14 550 per 100 000 of the population are infected with tuberculosis with cancer on the rise. These diseases require medicines which are mostly patented yet Ghana has access to medicine problems despite the existence of a national health insurance system. Ghana has however not fully incorporated the TRIPS flexibilities in its national legislations and therefore unable to fully utilise the flexibilities as an option to access essential medicines. Questions therefore remain as to why and how Ghana can utilise the flexibilities to improve access to medicines. Based on an examination of the WTO’s patent system and legislations of Ghana, this mini- thesis contends that, the extent of incorporation of the flexibilities are inadequate due to the existence of lacunas in the Ghanaian legislations. Furthermore, a comparative assessment with South Africa supports an understanding that conditions are not ripe for full utilisation of all the flexibilities. It further argues that the utilisation of the TRIPS flexibilities by Ghana has been rendered ineffective due to administrative, political, economic and social challenges which adversely affects the full utilisation of the flexibilities incorporated and those yet to be incorporated. It is therefore important that Ghana adopts holistic approaches taking into consideration best practices if the TRIPS flexibilities must be effectively utilised. This mini-thesis concludes that, the TRIPS flexibilities are necessary for accessing essential medicines in Ghana to promote the right to health and that a review of Ghana’s current legislations to fully incorporate the TRIPS flexibilities and addressing other non-legal challenges are the required linchpin for effective utilisation of the TRIPS flexibilities.

Comme plusieurs pays du monde, Madagascar a fait rentrer dans sa politique de santé, l’utilisation des médicaments génériques, de moindre coût, pour faciliter l’accès aux soins de la population. La promotion des médicaments génériques impose de garantir leur qualité par rapport aux médicaments de référence. Une étude a été menée pour contribuer à l’amélioration des pratiques du système de réglementation et des contrôles pharmaceutiques de Madagascar. Pour cela, l’environnement pharmaceutique et le système d’enregistrement des médicaments de ce pays sont présentés en regard de ceux existants dans d’autres pays. Ensuite, des contrôles de qualité englobant des essais physico-chimiques, pharmaco-techniques et pharmacologiques, sont réalisés sur vingt-deux médicaments antihypertenseurs dont quatre spécialités de références et dix-huit spécialités considérées comme leurs génériques, échantillonnés à Madagascar. L’augmentation incessante du nombre de malades atteints d’hypertension artérielle, couplée avec la difficulté de son traitement, sont à l’origine du choix de la famille thérapeutique étudiée. Pour les dix-huit spécialités considérées comme génériques, des non conformités aux référentiels ont été révélées. Seulement une spécialité considérée comme générique a présenté des caractéristiques, dont la cinétique de dissolution et les résultats pharmacologiques, similaires à celles de la référence. Des préconisations impliquant tous les acteurs du domaine pharmaceutiques ont pu être dégagées à partir de l’étude. / Like many countries in the world, Madagascar has returned in its health policy, the use of generic drugs, because of their lower cost, to facilitate access to health care of the population. The promotion of generic drugs needs to ensure their quality compared to reference drugs. A study was conducted to contribute to the improvement of practices and drug regulatory system in Madagascar . For this, the pharmaceutical environment and the registration of generic drugs in this country with those of other countries are presented. Then quality control tests were performed on twenty two antihypertensive drugs including four referent specialties and eighteen specialties considered as their generic, sampled in Madagascar . The choice of this therapeutic family was governed by the constant increase in the number of patients suffering from hypertension, associated with the difficulty of treatment. For the eighteen specialties considered as generics, non-compliances with standards were recorded at the end of the physicochemical and pharmacotechnical tests and pharmacological studies. Only one specialty was shown to present similar characteristics, including dissolution kinetics and pharmacological results, as the reference. Recommendations involving all stakeholders of the pharmaceutical field have been brought from the study.