Thesis (LL.D.)--University of Leiden / "Between legality and illegality: An inquiry into the doctrine of encroachment of rights and powers as a result of the corrective action of reasonableness and fairness in law with particular reference to the encroachment of ownership of immovable property" ...refer to full-text for more details which includes abstracts Afrikaans. Text in Afrikaans.

Priority setting for expensive biopharmaceuticals is one of the most important challenges for publicly funded health systems. One of the drivers of rising healthcare expenditures is pharmaceuticals (i.e., drugs). Moreover, people are living longer and their expectation of, and demand for, health care, drugs, and services are continually increasing. The overall aim of this research was to describe and evaluate reimbursement decisions for six expensive biopharmaceuticals across five countries in order to ascertain if the processes were legitimate and fair. I conducted qualitative case studies of six expensive biopharmaceuticals in order to describe and evaluate the priority setting activities of eight committees across five countries, including Canada, England and Wales, Australia, Israel and the United States. Data sources included: 1) 32 documents and 2) 56 interviews with informants. The recommendations process of each committee partially met the four conditions of ‘accountability for reasonableness’. My main finding is that, while a number of values were considered by committees when making reimbursement decisions, committees tended to focus on values of evidence, effectiveness and efficiency, but not the full range of relevant values. Thus, these contexts did not fully meet the conditions of legitimacy and fairness. I have provided an in-depth description of the eight committees’ priority setting activities regarding the study drugs, as well as committee members’, patients’ and industry representatives’ views regarding the process. I developed practical guidance for leaders for improving reimbursement decisions for expensive biopharmaceuticals, the implementation of which would enhance the fairness and legitimacy of priority setting. This study has demonstrated that in order to create a fair and legitimate drug reimbursement process, we need to ensure the incorporation of a wide range of values, and the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes.

Made available in DSpace on 2016-04-26T20:22:32Z (GMT). No. of bitstreams: 1 Renato Braz Mehanna Khamis.pdf: 688364 bytes, checksum: b4a34dedc1f4cbc842ae21d1e596e9a0 (MD5) Previous issue date: 2014-02-03 / The present study aims to verify the legal status of proportionality and reasonableness, aiming to clarify whether they are legal rules or not and, if so, what species. Moreover, when we check their legal natures, we will be able to clarify if they are the same thing with different names, or if indeed we are facing separate legal institutes / O presente trabalho tem por finalidade verificar a natureza jurídica da proporcionalidade e da razoabilidade, visando esclarecer se são normas jurídicas ou não e, em caso afirmativo, de que espécies. Ademais, ao verificarmos suas naturezas jurídicas, teremos a possibilidade de esclarecer se trata de uma mesma coisa com nomes distintos, ou se de fato estamos diante de institutos jurídicos distintos.

Submitted by Filipe dos Santos (fsantos@pucsp.br) on 2018-03-16T12:14:52Z No. of bitstreams: 1 Flávio Augusto Queiroz e Silva.pdf: 2433287 bytes, checksum: 5490f79c9ab1da67e63570796db0f518 (MD5) / Made available in DSpace on 2018-03-16T12:14:52Z (GMT). No. of bitstreams: 1 Flávio Augusto Queiroz e Silva.pdf: 2433287 bytes, checksum: 5490f79c9ab1da67e63570796db0f518 (MD5) Previous issue date: 2018-02-22 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES / This investigation inquires into the concept of “the growth of concrete reasonableness” in the philosophy of the pragmaticist Charles S. Peirce (1839 – 1914), addressing it as a fundamental idea in his work. As we have understood, the concept is not only important to comprehend Peirce’s philosophy, but it also structures his thought. In other words, we can understand this great, complex and vivid philosophy, as well as the classification of its branches, based on the “growth of concrete reasonableness”. Therefore, we have looked for the bedrocks of this idea in Peircean Phenomenology, Normative Sciences and Metaphysics. We will see that the idea of an incarnated reasonableness in the Universe, active and always growing, leads us directly to the heart of Peirce’s philosophy: pragmaticism, realism and the strong negation of any nominalist, individualistic and dogmatic ideals whatsoever / A pesquisa investiga o conceito de "crescimento da razoabilidade concreta" na filosofia do pragmaticista norte-americano Charles S. Peirce (1839 – 1914), tratando-o como ideia fundamental de sua obra. Entendemos ser um conceito importante para entender a filosofia do autor porque é estruturante de seu pensamento. Em outras palavras, podemos entender a grande, complexa e viva filosofia de Peirce, assim como a estruturação e classificação de seus ramos, a partir do “crescimento da razoabilidade”. Para isso, buscamos os alicerces desta ideia na Fenomenologia, nas Ciências Normativas e na Metafísica do autor. Veremos, com este percurso, que a ideia de uma razoabilidade encarnada no Universo, atuante e sempre em crescimento, permite-nos aceder diretamente ao coração da filosofia peirciana: o pragmaticismo, o realismo e a negação ferrenha de qualquer postura nominalista, individualista e dogmática

Priority setting for expensive biopharmaceuticals is one of the most important challenges for publicly funded health systems. One of the drivers of rising healthcare expenditures is pharmaceuticals (i.e., drugs). Moreover, people are living longer and their expectation of, and demand for, health care, drugs, and services are continually increasing. The overall aim of this research was to describe and evaluate reimbursement decisions for six expensive biopharmaceuticals across five countries in order to ascertain if the processes were legitimate and fair. I conducted qualitative case studies of six expensive biopharmaceuticals in order to describe and evaluate the priority setting activities of eight committees across five countries, including Canada, England and Wales, Australia, Israel and the United States. Data sources included: 1) 32 documents and 2) 56 interviews with informants. The recommendations process of each committee partially met the four conditions of ‘accountability for reasonableness’. My main finding is that, while a number of values were considered by committees when making reimbursement decisions, committees tended to focus on values of evidence, effectiveness and efficiency, but not the full range of relevant values. Thus, these contexts did not fully meet the conditions of legitimacy and fairness. I have provided an in-depth description of the eight committees’ priority setting activities regarding the study drugs, as well as committee members’, patients’ and industry representatives’ views regarding the process. I developed practical guidance for leaders for improving reimbursement decisions for expensive biopharmaceuticals, the implementation of which would enhance the fairness and legitimacy of priority setting. This study has demonstrated that in order to create a fair and legitimate drug reimbursement process, we need to ensure the incorporation of a wide range of values, and the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes.

Whenever states’ rights to regulate and investor’s interests conflict with each other it is an unsolved question in investment treaty arbitration how one should balance those two positions. In particular, it is indefinite where to draw the line at what point states can actually exercise their rights without unlawfully violating the investor’s interests. A solution for this issue might be the proportionality test or analysis. Over the years, several tribunals approached proportionality, but took very different paths to understand and apply this legal concept. Especially, if one considers proportionality from its root in European and German law, some applications in investment treaty arbitration create confusion. Originating from a fixed methodological approach in the background of justifications of state measures, tribunals use proportionality in the process of defining and determining in contrast to the justification, as one would expect. Thus, it remains questionable which of those approaches is correct or if there is rather one correct application of proportionality in the context of investment treaty arbitration. This work argues in favour of proportionality being a legal concept which originates from German and European jurisprudence and migrated to international law. In international law it was established as a legal principle and subsequently adopted, inter alia, in investment treaty arbitration. Nevertheless, tribunals should be more careful when using proportionality. Especially, when naming and transferring a particular legal construct, it should not be used out of context. This endangers an award’s persuasiveness and furthers the fragmentation in international investment law. Tribunals should only refer to the ‘principle of proportionality’ or a ‘proportionality test/analysis’ when they actually apply it. And this application requires the concept to be used in the background of justification and not determination. Furthermore, the three/four significant steps must be followed in order to obtain the aimed proportional result.

Background During the 1990s, Tanzania, like many other developing countries, adopted health sector reforms. The most common policy change under health sector reforms has been decentralisation, which involves the transfer of power and authority from the central levels to the local governments. However, while decentralisation of health care planning and priority-setting in Tanzania gained currency in the last decade, its performance has, so far, been less than satisfactory. In a five-year EU-supported project, which started in 2006, ways of strengthening fairness and accountability in priority-setting in district health management were studied through action research. As part of this overall project, this doctoral thesis aims to analyse the existing health care organisation and management systems, and explore the potential and challenges of implementing Accountability for Reasonableness approach to priority setting in Tanzania. Methods A qualitative case study in Mbarali district formed the basis of exploring the socio-political and institutional contexts within which health care decision-making takes place. The thesis also explores how the Accountability for Reasonableness intervention was shaped, enabled and constrained by the interaction between the contexts and mechanisms. Key informant interviews were conducted with the Council Health Management Team, local government officials, and other stakeholders, using a semi-structured interview guide. Relevant documents were also gathered and group priority-setting processes in the district were observed. Main findings The study revealed that, despite the obvious national rhetoric on decentralisation, actual practice in the district involved little community participation. The findings showed that decentralisation, in whatever form, does not automatically provide space for community engagement. The assumption that devolution to local government promotes transparency, accountability and community participation, is far from reality. In addition, the thesis found that while the Accountability for Reasonableness approach to priority setting was perceived to be helpful in strengthening transparency, accountability, stakeholder engagement and fairness, integrating the innovation into the current district health system was challenging.   Conclusion This thesis underscores the idea that greater involvement and accountability among local actors may increase the legitimacy and fairness of priority-setting decisions. A broader and more detailed analysis of health system elements, and socio-cultural context, can lead to better prediction of the effects of the innovation, pinpoint stakeholders’ concerns, and thereby illuminate areas requiring special attention in fostering sustainability. Additionally, the thesis stresses the need to recognise and deal with power asymmetries among various actors in priority-setting contexts.

O presente trabalho busca examinar o conteúdo normativo de regras e limites de dedutibilidade do imposto de renda no ordenamento jurídico brasileiro. Pretende-se analisar a sua relevância como um instrumento de proteção de direitos fundamentais e de realização da igualdade tributária por meio da simplificação que proporciona. Com base nessa premissa, pretende-se, primeiro, afastar o entendimento de que regras e limites de dedutibilidade são fruto da discricionariedade legislativa e, segundo, apresentar parâmetros de controle que permitam o seu controle jurisdicional. / The presente study aims to examine the normative content of deductions in the context of income tax in brazilian law. Its purpose is to analyze the relevance of deductions as an instrument of protection of fundamental rights and achieving equality through tax simplification. Based on this premise, it seeks, first, overcome the understanding that deductibility rules and limits are the result of legislative discretion and, second, provide control parameters that allow its jurisdictional control.

O presente trabalho busca examinar o conteúdo normativo de regras e limites de dedutibilidade do imposto de renda no ordenamento jurídico brasileiro. Pretende-se analisar a sua relevância como um instrumento de proteção de direitos fundamentais e de realização da igualdade tributária por meio da simplificação que proporciona. Com base nessa premissa, pretende-se, primeiro, afastar o entendimento de que regras e limites de dedutibilidade são fruto da discricionariedade legislativa e, segundo, apresentar parâmetros de controle que permitam o seu controle jurisdicional. / The presente study aims to examine the normative content of deductions in the context of income tax in brazilian law. Its purpose is to analyze the relevance of deductions as an instrument of protection of fundamental rights and achieving equality through tax simplification. Based on this premise, it seeks, first, overcome the understanding that deductibility rules and limits are the result of legislative discretion and, second, provide control parameters that allow its jurisdictional control.

O presente trabalho busca examinar o conteúdo normativo de regras e limites de dedutibilidade do imposto de renda no ordenamento jurídico brasileiro. Pretende-se analisar a sua relevância como um instrumento de proteção de direitos fundamentais e de realização da igualdade tributária por meio da simplificação que proporciona. Com base nessa premissa, pretende-se, primeiro, afastar o entendimento de que regras e limites de dedutibilidade são fruto da discricionariedade legislativa e, segundo, apresentar parâmetros de controle que permitam o seu controle jurisdicional. / The presente study aims to examine the normative content of deductions in the context of income tax in brazilian law. Its purpose is to analyze the relevance of deductions as an instrument of protection of fundamental rights and achieving equality through tax simplification. Based on this premise, it seeks, first, overcome the understanding that deductibility rules and limits are the result of legislative discretion and, second, provide control parameters that allow its jurisdictional control.