In 1994, the members of the World Trade Organisation (WTO) adopted the Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPs Agreement") and thus committed themselves to respect certain standards for intellectual property protection. This thesis studies the scope of the standards for patent protection and their impact upon trade in medicines. The first part addresses the international dimension of the issue and explains how international trade in medicines can contribute to enhancing the level of global welfare. The first chapter argues that in order to fulfil this latter objective legislation relating to patents must be adapted to the economic and social situation of countries. The second chapter demonstrates that such adaptation is not only allowed, but is indeed encouraged by the provisions of the TRIPS Agreement. The second part of this thesis addresses the issue from a Canadian perspective, and discusses the way Canadian patent provisions applying to pharmaceuticals should be drafted so as to allow Canada to participate in---and to benefit from---international trade in medicines. Thus, I first analyse the factual, political, and legislative factors that influence the Canadian pharmaceutical industry. I then study the role of Canada as part of the integrated market for medicines, as well as the social, industrial and economic objectives underlying Canadian policies. I finally propose some modifications and adaptations to the Canadian Patent Act and suggest some orientations for future multilateral negotiations.

Em virtude da necessidade de se disponibilizar medicamentos nos serviços de atenção à saúde e da utilização racional deste insumo, torna-se imperativo organizar a Assistência Farmacêutica (AF) e reorientar a atuação do farmacêutico no Sistema Único de Saúde (SUS), aproximando-o do usuário. O objetivo deste estudo foi avaliar um treinamento em dispensação para promoção do uso racional de medicamentos, composto por sete módulos, aplicado aos farmacêuticos da rede de atenção à saúde de municípios de São Paulo. A estruturação do treinamento se deu a partir do levantamento das necessidades dos serviços de atenção à saúde em relação ao farmacêutico, da definição do seu papel nestes serviços e das competências a serem desenvolvidas para o desempenho desse papel. Para aplicação do treinamento utilizou-se o método de ensino baseado em problemas. A estratégia adotada para esta avaliação foi a aplicação de um mesmo questionário pré e pós-treinamento, seguido pela medida das diferenças encontradas nas respostas fornecidas por cada farmacêutico e pelo grupo de farmacêuticos, antes e depois do treinamento. A avaliação dos módulos de treinamentos não mostrou diferenças significativas entre as médias de acertos das questões, antes e após a sua aplicação. A análise das respostas mostrou que é necessário melhor esclarecer o papel do farmacêutico no SUS e, ainda, promover o desenvolvimento de habilidades para a busca de informação sobre medicamentos, a realização de estudos para a sua utilização e identificação de reações adversas aos mesmos. / In need to provide medicines in health care services and rational use of this input, it is imperative to organize the Pharmaceutical Assistance and redirect the actions of the pharmacist in the Brazilian Public Health System (SUS), approaching him to the user. The objective of this study is to evaluate a training in dispensing to promote the rational use of medicines, composed of seven modules, applied to the pharmacists linked to the health care network in municipalities of São Paulo. The structuring of the training came from the needs of health care services in relation to pharmacists, the definition of their role in these services and skills that would be developed to perform this role. The training application is founded on the basedproblem education method. The strategy for this evaluation was the application of the same questionnaire before and after training, followed by measuring the differences responses provided by each pharmacist and the pharmaceutical group, before and after training. The evaluation of the modules for training showed no significant differences between the means of correct questions before and after its implementation. The analysis of responses showed that it is necessary clarify the role of the pharmacist in the Unified Health System, and also promote the development of skills for searching of information on drugs, studies for its use and identification of adverse reactions.

Em virtude da necessidade de se disponibilizar medicamentos nos serviços de atenção à saúde e da utilização racional deste insumo, torna-se imperativo organizar a Assistência Farmacêutica (AF) e reorientar a atuação do farmacêutico no Sistema Único de Saúde (SUS), aproximando-o do usuário. O objetivo deste estudo foi avaliar um treinamento em dispensação para promoção do uso racional de medicamentos, composto por sete módulos, aplicado aos farmacêuticos da rede de atenção à saúde de municípios de São Paulo. A estruturação do treinamento se deu a partir do levantamento das necessidades dos serviços de atenção à saúde em relação ao farmacêutico, da definição do seu papel nestes serviços e das competências a serem desenvolvidas para o desempenho desse papel. Para aplicação do treinamento utilizou-se o método de ensino baseado em problemas. A estratégia adotada para esta avaliação foi a aplicação de um mesmo questionário pré e pós-treinamento, seguido pela medida das diferenças encontradas nas respostas fornecidas por cada farmacêutico e pelo grupo de farmacêuticos, antes e depois do treinamento. A avaliação dos módulos de treinamentos não mostrou diferenças significativas entre as médias de acertos das questões, antes e após a sua aplicação. A análise das respostas mostrou que é necessário melhor esclarecer o papel do farmacêutico no SUS e, ainda, promover o desenvolvimento de habilidades para a busca de informação sobre medicamentos, a realização de estudos para a sua utilização e identificação de reações adversas aos mesmos. / In need to provide medicines in health care services and rational use of this input, it is imperative to organize the Pharmaceutical Assistance and redirect the actions of the pharmacist in the Brazilian Public Health System (SUS), approaching him to the user. The objective of this study is to evaluate a training in dispensing to promote the rational use of medicines, composed of seven modules, applied to the pharmacists linked to the health care network in municipalities of São Paulo. The structuring of the training came from the needs of health care services in relation to pharmacists, the definition of their role in these services and skills that would be developed to perform this role. The training application is founded on the basedproblem education method. The strategy for this evaluation was the application of the same questionnaire before and after training, followed by measuring the differences responses provided by each pharmacist and the pharmaceutical group, before and after training. The evaluation of the modules for training showed no significant differences between the means of correct questions before and after its implementation. The analysis of responses showed that it is necessary clarify the role of the pharmacist in the Unified Health System, and also promote the development of skills for searching of information on drugs, studies for its use and identification of adverse reactions.

Em virtude da necessidade de se disponibilizar medicamentos nos serviços de atenção à saúde e da utilização racional deste insumo, torna-se imperativo organizar a Assistência Farmacêutica (AF) e reorientar a atuação do farmacêutico no Sistema Único de Saúde (SUS), aproximando-o do usuário. O objetivo deste estudo foi avaliar um treinamento em dispensação para promoção do uso racional de medicamentos, composto por sete módulos, aplicado aos farmacêuticos da rede de atenção à saúde de municípios de São Paulo. A estruturação do treinamento se deu a partir do levantamento das necessidades dos serviços de atenção à saúde em relação ao farmacêutico, da definição do seu papel nestes serviços e das competências a serem desenvolvidas para o desempenho desse papel. Para aplicação do treinamento utilizou-se o método de ensino baseado em problemas. A estratégia adotada para esta avaliação foi a aplicação de um mesmo questionário pré e pós-treinamento, seguido pela medida das diferenças encontradas nas respostas fornecidas por cada farmacêutico e pelo grupo de farmacêuticos, antes e depois do treinamento. A avaliação dos módulos de treinamentos não mostrou diferenças significativas entre as médias de acertos das questões, antes e após a sua aplicação. A análise das respostas mostrou que é necessário melhor esclarecer o papel do farmacêutico no SUS e, ainda, promover o desenvolvimento de habilidades para a busca de informação sobre medicamentos, a realização de estudos para a sua utilização e identificação de reações adversas aos mesmos. / In need to provide medicines in health care services and rational use of this input, it is imperative to organize the Pharmaceutical Assistance and redirect the actions of the pharmacist in the Brazilian Public Health System (SUS), approaching him to the user. The objective of this study is to evaluate a training in dispensing to promote the rational use of medicines, composed of seven modules, applied to the pharmacists linked to the health care network in municipalities of São Paulo. The structuring of the training came from the needs of health care services in relation to pharmacists, the definition of their role in these services and skills that would be developed to perform this role. The training application is founded on the basedproblem education method. The strategy for this evaluation was the application of the same questionnaire before and after training, followed by measuring the differences responses provided by each pharmacist and the pharmaceutical group, before and after training. The evaluation of the modules for training showed no significant differences between the means of correct questions before and after its implementation. The analysis of responses showed that it is necessary clarify the role of the pharmacist in the Unified Health System, and also promote the development of skills for searching of information on drugs, studies for its use and identification of adverse reactions.

O Sistema Único de Saúde (SUS), sistema público de saúde brasileiro, tem evoluído continuamente para se adaptar aos novos desafios da área de saúde e as novas necessidades da população. Entre os aprimoramentos para atender a esses desafios está a oferta de medicamentos de alto custo à população por meio de farmácias de medicamentos especializados como a de Ribeirão Preto, que atende aos residentes no município e também as pessoas das cidades englobadas pela DRS XIII. Com o objetivo de analisar o processo de uma farmácia de medicamentos especializados, identificando os problemas e propondo melhorias foi aplicada a metodologia lean healthcare. Inicialmente foi realizada uma pesquisa juntamente aos usuários desse serviço em busca de uma definição do valor no serviço prestado pela farmácia. Os resultados encontrados mostram que receber todos os medicamentos solicitados, a correta orientação em relação as dúvidas, pouco tempo de espera na fila e o bom atendimento são os itens mais valorizados por eles. A partir dessa definição de valor, de entrevistas com funcionários da farmácia e de observações no local, foram criados mapas do fluxo de valor do processo de trabalho da farmácia, identificando os desperdícios praticados e apontando sugestões de melhorias através da aplicação da metodologia lean healthcare. Após a finalização dessa etapa foram criadas propostas para a melhoria do fluxo contínuo, para o estabelecimento da demanda puxada e para a melhoria contínua. Além disso, realizou-se uma análise crítica dos resultados obtidos em que se pôde perceber que as soluções aos problemas vivenciados pela farmácia possuem diferentes graus de dificuldade de implantação, porém, apresentam grande potencial para a melhoria do valor entregue ao público da farmácia. Verificou-se também que a má distribuição do seu espaço físico, a divisão dos estoques em diferentes unidades e a falta de medicamentos são origens de grandes desperdícios. Assim, foi sugerida a inclusão de outras etapas ao modelo de implantação do lean utilizado para que seja alcançada a maior participação da equipe de trabalho da farmácia e para que o lean healthcare seja implantado de maneira completa, com foco na busca da perfeição e não se limitando a solução de problemas pontuais. / The Unified Health System (SUS), the Brazilian public health system, has continuously evolved to adapt to the new challenges of the healthcare and the new requirements of the population. The offering of the high-cost medicines is between the enhancements to meet these challenges and it`s dispensation is conducted to the population through specialized medicine pharmacies like the Ribeirão Preto pharmacy, which serves the people of this city and also the people of the cities encompassed by the DRS XIII. In order to analyze the process of specialized medicines pharmacy identifying problems and proposing improvements was applied the lean methodology healthcare. Initially a survey was conducted among the users of that service aiming the definition of what was most important to them in the services provided by the pharmacy. The results show that receive all required medicines, be well oriented about the doubts, stay a short time in the queue and be well attended are the most valued items by them. From this definition, interviews with pharmacy staff and on-site observations, the value stream maps were created enabling to understand the pharmacy work process, identify the waste and aiming suggestions for improvements through the application of lean healthcare tools. After this stage, proposals were designed to improve the continuous stream, for the establishment of the pull demand and the continuous improvement. In addition, was conducted a critical analysis of the results and is possible to realize that the solutions to the problems experienced by the pharmacy features different degrees of difficulty implementation, however, offers a great potential to improve the value delivered to the pharmacy public. It was also found that the poor distribution of its physical space, the division of stocks in different units and lack of medicines are the major sources of the waste observed. Thus, was suggested the inclusion of other steps to the lean implementation model, in order to reach greater involvement of the pharmacy work team and to implement the lean healthcare completely, focusing on the pursuit of perfection and not limiting the solution of specific problems.

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Yes / Introduction Heart failure affects 26 million people globally, approximately 900 thousand people in the UK, and is increasing in incidence. Appropriate management of medicines for heart failure at the time of hospital discharge reduces readmissions, improves quality of life and increases survival. The Improving the Safety and Continuity Of Medicines management at Transitions (ISCOMAT) trial tests the effectiveness of the Medicines at Transition Intervention (MaTI), which aims to enhance self-care and increase community pharmacy involvement in the medicines management of heart failure patients. Methods and analysis ISCOMAT is a parallel-group cluster randomised controlled trial, randomising 42 National Health Service trusts with cardiology wards in England on a 1:1 basis to implement the MaTI or treatment as usual. Around 2100 patients over the age of 18 admitted to hospital with heart failure with at least moderate left ventricular systolic dysfunction within the last 5 years, and planned discharge to the geographical area of the cluster will be recruited. The MaTI consists of training for staff, a toolkit for participants, transfer of discharge information to community pharmacies and a medicines reconciliation/review. Treatment as usual is determined by local policy and practices. The primary outcome is a composite of all-cause mortality and heart failure-related hospitalisation at 12 months postregistration obtained from national electronic health records. The key secondary outcome is continued prescription of guideline-indicated therapies at 12 months measured via patient-reported data and Hospital Episode Statistics. The trial contains a parallel mixed-methods process evaluation and an embedded health economics study. / The study was funded as part of a National Institute for Health Research Programme Grant for Applied Research (RP-PG-0514-20009).

Generic medicines are very important in driving down the health care cost. In a country like South Africa, where more than 80% of the population depend on the state health care, it is important to find ways to reduce cost. The main aim of the study was to evaluate the attitude towards generic medicines by pharmacists in Gauteng province of South Africa. Gauteng as the economic hub of the country, with the highest population and the highest number of pharmacies and pharmacists, obtaining a picture around the attitude towards generic medicines would help the all the stakeholders in the health care sector to identify areas of concern and address them to drive a positive attitude. In order to evaluate the attitude, Fishbein models, which noted the intention to perform the behaviour in question as the immediate antecedent of any behaviour, were used. The models identified two conceptually independent determinants of intention, which are attitude towards the behaviour (personal) and subjective norm (social). Depending of which model one is using, one more determinant of the intention “perceived behavioural control” can be added on the theory of reasoned action to form model of planned behaviour. By evaluating the attitude one can therefore determine the level of intention to perform the behaviour of interest which is generic substitution in this study. An empirical study was conducted among 116 pharmacists and assistants in Gauteng province. The methodology included research design, instrument development, sampling methods, data collection, capturing and statistical analysis. The results were analysed using Cronbach Alpha coefficients to measure reliability of the research instrument, t-test and ANOVA to test the hypothesis and the variance between groups; the effect sizes and Spearman's rho to determine the correlation and relationship between two variables of interest. The results of the study showed that, 94% of the respondents believe that generics are viable alternatives to innovator medicines. On the question of pharmacists’ attitude towards generic medicines results showed that there was no significant difference in almost all the demographic characteristics gender, age, qualifications, employment level, years of experience and type of pharmacy one practices. The only significant driver of the difference in attitude is the location of the pharmacy where pharmacists practicing in the townships and the city centre were found to be more receptive to generics than those in the suburbs. Due to reliability failure on the control belief construct, the theory of planned behaviour was downgraded to theory of reasoned action, to exclude the control belief construct for further statistical analysis. Correlation between the two attitudes constructs, behavioural belief and evaluation of behavioural outcome was one of the highest, where behavioural belief was identified as the direct measure of attitude and also the main driver. The study concluded that attitude is one of the most important personal factors influencing both the organisation and individual consumer buying behaviour. Evaluating individuals’ attitude to the behaviour (use of a product or service) would help marketers to communicate the right message to the right customers. / MBA, North-West University, Potchefstroom Campus, 2015

Generic medicines are very important in driving down the health care cost. In a country like South Africa, where more than 80% of the population depend on the state health care, it is important to find ways to reduce cost. The main aim of the study was to evaluate the attitude towards generic medicines by pharmacists in Gauteng province of South Africa. Gauteng as the economic hub of the country, with the highest population and the highest number of pharmacies and pharmacists, obtaining a picture around the attitude towards generic medicines would help the all the stakeholders in the health care sector to identify areas of concern and address them to drive a positive attitude. In order to evaluate the attitude, Fishbein models, which noted the intention to perform the behaviour in question as the immediate antecedent of any behaviour, were used. The models identified two conceptually independent determinants of intention, which are attitude towards the behaviour (personal) and subjective norm (social). Depending of which model one is using, one more determinant of the intention “perceived behavioural control” can be added on the theory of reasoned action to form model of planned behaviour. By evaluating the attitude one can therefore determine the level of intention to perform the behaviour of interest which is generic substitution in this study. An empirical study was conducted among 116 pharmacists and assistants in Gauteng province. The methodology included research design, instrument development, sampling methods, data collection, capturing and statistical analysis. The results were analysed using Cronbach Alpha coefficients to measure reliability of the research instrument, t-test and ANOVA to test the hypothesis and the variance between groups; the effect sizes and Spearman's rho to determine the correlation and relationship between two variables of interest. The results of the study showed that, 94% of the respondents believe that generics are viable alternatives to innovator medicines. On the question of pharmacists’ attitude towards generic medicines results showed that there was no significant difference in almost all the demographic characteristics gender, age, qualifications, employment level, years of experience and type of pharmacy one practices. The only significant driver of the difference in attitude is the location of the pharmacy where pharmacists practicing in the townships and the city centre were found to be more receptive to generics than those in the suburbs. Due to reliability failure on the control belief construct, the theory of planned behaviour was downgraded to theory of reasoned action, to exclude the control belief construct for further statistical analysis. Correlation between the two attitudes constructs, behavioural belief and evaluation of behavioural outcome was one of the highest, where behavioural belief was identified as the direct measure of attitude and also the main driver. The study concluded that attitude is one of the most important personal factors influencing both the organisation and individual consumer buying behaviour. Evaluating individuals’ attitude to the behaviour (use of a product or service) would help marketers to communicate the right message to the right customers. / MBA, North-West University, Potchefstroom Campus, 2015

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