>Magister Scientiae - MSc / Nanomedicines are loosely defined as medicines that seek to apply nanotechnology. Currently, nanomedicines are available for clinical use, including treatments for cancer, high cholesterol, hepatitis, COVID-19 vaccination, among other uses (Patra et al., 2018; Gao et al., 2021). Most of the nanomedicines meet the definition of medicines according to various national legislations. Consequently, these products are regulated as medicines. Nanomedicines present major differences in biological details and increased complexity of clinical use. They integrate different technology subsets from therapeutics to imaging and integrated non-invasive diagnosis (Gaspar, 2007). These complexities require extra regulatory effort.

Os genéricos surgiram na década de 60 nos Estados e são medicamentos que, no geral, são mais baratos que os inovadores; por isso têm um papel importante no controle e diminuição dos preços dos medicamentos. Os preços mais baixos devem-se a economia com o desenvolvimento e testes clínicos pois esses investimentos já foram realizados pela empresa detentora do medicamento inovador. Em 1999 com a promulgação da Lei 9.787, foi instituída a política de Medicamentos Genéricos no Brasil. A nova Legislação introduziu uma série de inovações e exigências na produção, testes de qualidade e bioequivalência, prescrição, dispensação e preços de medicamentos. Houve reações contrárias iniciais para as quais o Governo teve que tomar medidas regulamentadoras para tentar corrigir os problemas que surgiram. O objetivo do trabalho é analisar as situações que levaram a adoção de tais medidas e sua eficácia. Propõem-se fazer uma analise das mudanças da Legislação de medicamentos genéricos no Brasil durante o período de 1999 a 2002 tendo como pano de fundo as características do mercado farmacêutico brasileiro e as reações do mercado. Para tanto, foram utilizadas notícias em jornais de grande circulação, bem como entrevistas com membros do órgão regulador e da indústria farmacêutica. A legislação brasileira será ainda analisada sob a óptica das recomendações da Organização Mundial da Saúde a fim de termos parâmetros qualitativos para averiguar a sua qualidade e finalmente analisar a influência da mídia e da política nos resultados obtidos pelos genéricos. As alterações da Legislação mostraram-se um artifício interessante para auxiliar o processo de implantação dos genéricos no Brasil e auxiliaram na obtenção dos resultados positivos obtidos no processo de implantação dos genéricos. / Generics first appeared in the United States in the 1960’s, and they are medications which, by and large, are less expensive than the innovative ones. This is why they have an important role in controlling and reducing medication prices. The lower prices are due to the savings with development and clinical tests, since these investments have already been made by the innovative medication proprietor. In 1999, with the promulgation of Law 9.787, a Generic Medication policy was instituted in Brazil. The new Legislation introduced a series of production innovations and demands, product quality and bioequivalence tests, as well as medication prescriptions, dispensations and pricing practices. Initial contrary reactions and problems occurred, forcing the Government to make corrective regulatory measures. This research project aims at analyzing both the conditions that lead to such measures being taken and their efficacy. The proposal herein is to analyze the changes made to the generic medication Legislation in Brazil between 1999 and 2002, keeping the Brazilian pharmaceutical market characteristics and market reactions as a backdrop and also relying on articles published in the major newspapers and on interviews made with members of both the regulation agency and of the pharmaceutical industry. The Brazilian Legislation will also be analyzed from the angle of the World Health Organization’s recommendations in order to provide qualitative parameters to evaluate its quality and, finally, to analyze media and political influence in the results the generic medications reached. Legislation manipulation revealed to be an interesting device to assist in the generic implanting process in Brazil and helped in reaching the positive results obtained in such process.

Os genéricos surgiram na década de 60 nos Estados e são medicamentos que, no geral, são mais baratos que os inovadores; por isso têm um papel importante no controle e diminuição dos preços dos medicamentos. Os preços mais baixos devem-se a economia com o desenvolvimento e testes clínicos pois esses investimentos já foram realizados pela empresa detentora do medicamento inovador. Em 1999 com a promulgação da Lei 9.787, foi instituída a política de Medicamentos Genéricos no Brasil. A nova Legislação introduziu uma série de inovações e exigências na produção, testes de qualidade e bioequivalência, prescrição, dispensação e preços de medicamentos. Houve reações contrárias iniciais para as quais o Governo teve que tomar medidas regulamentadoras para tentar corrigir os problemas que surgiram. O objetivo do trabalho é analisar as situações que levaram a adoção de tais medidas e sua eficácia. Propõem-se fazer uma analise das mudanças da Legislação de medicamentos genéricos no Brasil durante o período de 1999 a 2002 tendo como pano de fundo as características do mercado farmacêutico brasileiro e as reações do mercado. Para tanto, foram utilizadas notícias em jornais de grande circulação, bem como entrevistas com membros do órgão regulador e da indústria farmacêutica. A legislação brasileira será ainda analisada sob a óptica das recomendações da Organização Mundial da Saúde a fim de termos parâmetros qualitativos para averiguar a sua qualidade e finalmente analisar a influência da mídia e da política nos resultados obtidos pelos genéricos. As alterações da Legislação mostraram-se um artifício interessante para auxiliar o processo de implantação dos genéricos no Brasil e auxiliaram na obtenção dos resultados positivos obtidos no processo de implantação dos genéricos. / Generics first appeared in the United States in the 1960’s, and they are medications which, by and large, are less expensive than the innovative ones. This is why they have an important role in controlling and reducing medication prices. The lower prices are due to the savings with development and clinical tests, since these investments have already been made by the innovative medication proprietor. In 1999, with the promulgation of Law 9.787, a Generic Medication policy was instituted in Brazil. The new Legislation introduced a series of production innovations and demands, product quality and bioequivalence tests, as well as medication prescriptions, dispensations and pricing practices. Initial contrary reactions and problems occurred, forcing the Government to make corrective regulatory measures. This research project aims at analyzing both the conditions that lead to such measures being taken and their efficacy. The proposal herein is to analyze the changes made to the generic medication Legislation in Brazil between 1999 and 2002, keeping the Brazilian pharmaceutical market characteristics and market reactions as a backdrop and also relying on articles published in the major newspapers and on interviews made with members of both the regulation agency and of the pharmaceutical industry. The Brazilian Legislation will also be analyzed from the angle of the World Health Organization’s recommendations in order to provide qualitative parameters to evaluate its quality and, finally, to analyze media and political influence in the results the generic medications reached. Legislation manipulation revealed to be an interesting device to assist in the generic implanting process in Brazil and helped in reaching the positive results obtained in such process.

Magister Pharmaceuticae - MPharm / Efforts to improve the quality of service delivery are an ongoing feature in different organisations. In the private health care sector, particularly pharmaceutical services in private hospitals, such efforts are important because of the sector’s commercial nature. This stems from the fact that customers pay a lot of money for services and expect services that are worth the money they pay. A private health care delivery group encourages such efforts in pharmacies of its hospitals through scientific research.Service providers and consumers were engaged to gain an appreciation of quality service delivery. The qualitative research method was used for the reason that it is scientific research that seeks to provide understanding and insight into social experiences as appreciated by the people involved and that it is a process of disciplined investigation that is methodical and verifiable.The research project was conducted to identify factors that influence pharmaceutical service delivery, to establish the understanding of quality pharmaceutical service delivery and establish the expectations of customers regarding pharmaceutical service rendered in a private hospital group.