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Canábis medicinal: estado da arte da regulamentação em Portugal e comparação com países de referência
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Abstract(s)
Esta tese tem como objetivo analisar o estado da arte da regulamentação da canábis medicinal em Portugal, bem como compará-lo com as políticas adotadas por países de referência, nomeadamente Alemanha, Holanda, Itália, Canadá, Estados Unidos da América e Israel.
O estudo começa por contextualizar a evolução global da regulamentação da canábis medicinal, destacando a crescente aceitação e legalização da planta em várias partes do mundo. Portugal, seguindo esta tendência, legalizou o uso da canábis medicinal em 2018, proporcionando um contexto atual para a análise.
Em termos europeus, também é estudado o impacto da regulamentação europeia do medicamento, nomeadamente das Boas Práticas Agrícolas e de Colheita (GACP), Boas Práticas de Fabrico (GMP), Medicamentos à Base de Plantas (HMP), Medicamentos para Uso Humano (CHMP).
A pesquisa investiga a regulamentação em Portugal, abordando a legislação subjacente, os critérios para a prescrição e o acesso dos pacientes à canábis medicinal, bem como eventuais obstáculos enfrentados.
Da comparação com os países de referência mencionados, são analisadas as políticas de canábis medicinal, incluindo as leis, regulamentos, padrões de prescrição e uso. Essa comparação internacional destaca as desiguais abordagens adotadas pelas diferentes nações e permite identificar boas práticas e desafios comuns.
A tese conclui com uma síntese das principais descobertas e lições aprendidas com a análise comparativa. Ela pretende contribuir para um entendimento mais amplo da regulamentação da canábis medicinal em Portugal e o seu caminho futuro para uma melhor legislação acerca deste tema, à luz das experiências de outros países de referência.
This thesis aims to analyze the state of the art in the regulation of medical cannabis in Portugal and compare it with the policies adopted by reference countries, namely Germany, the Netherlands, Italy, Canada, the United States, and Israel. The study begins by providing a global context for the evolution of medical cannabis regulation, highlighting the increasing acceptance and legalization of the plant in various parts of the world. Portugal, in line with this trend, legalized the use of medical cannabis in 2018, providing a current context for the analysis. Within the European context, the impact of European pharmaceutical regulation will also be examined, including Good Agricultural and Collection Practices (GACP), Good Manufacturing Practices (GMP), Herbal Medicinal Products (HMP), and Human Medicinal Products (CHMP). The research delves into the regulatory framework in Portugal, addressing the underlying legislation, criteria for prescription, and patient access to medical cannabis, as well as any obstacles encountered. The central part of the thesis involves a comparative analysis with the aforementioned reference countries. For each of these countries, policies on medical cannabis, including laws, regulations, prescription standards, and usage, are examined. This international comparison highlights the different approaches taken by these nations and enables the identification of best practices and common challenges. The thesis concludes with a synthesis of the main findings and lessons learned from the comparative analysis. It aims to contribute to a broader understanding of medical cannabis regulation in Portugal and its future path towards improved legislation on this subject, drawing insights from the experiences of other reference countries.
This thesis aims to analyze the state of the art in the regulation of medical cannabis in Portugal and compare it with the policies adopted by reference countries, namely Germany, the Netherlands, Italy, Canada, the United States, and Israel. The study begins by providing a global context for the evolution of medical cannabis regulation, highlighting the increasing acceptance and legalization of the plant in various parts of the world. Portugal, in line with this trend, legalized the use of medical cannabis in 2018, providing a current context for the analysis. Within the European context, the impact of European pharmaceutical regulation will also be examined, including Good Agricultural and Collection Practices (GACP), Good Manufacturing Practices (GMP), Herbal Medicinal Products (HMP), and Human Medicinal Products (CHMP). The research delves into the regulatory framework in Portugal, addressing the underlying legislation, criteria for prescription, and patient access to medical cannabis, as well as any obstacles encountered. The central part of the thesis involves a comparative analysis with the aforementioned reference countries. For each of these countries, policies on medical cannabis, including laws, regulations, prescription standards, and usage, are examined. This international comparison highlights the different approaches taken by these nations and enables the identification of best practices and common challenges. The thesis concludes with a synthesis of the main findings and lessons learned from the comparative analysis. It aims to contribute to a broader understanding of medical cannabis regulation in Portugal and its future path towards improved legislation on this subject, drawing insights from the experiences of other reference countries.
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Keywords
Canábis medicinal Terapêutica Regulamentação Medicamento Medical cannabis Therapeutics Regulation Drug