Magister Legum - LLM

Essential Medicine Lists (EMLs) are important for the prioritization and availability of medicines around the world. Since the first Model List of Essential Medicines (MLEM) from the World Health Organization in 1977, the list has expanded from 208 to 479 medicines. The availability of essential medicines is a key priority under the World Health Organization’s Universal Health Coverage agenda & the United Nation’s Sustainable Development Goals (in particular goal 3.8 Coverage of Essential Health Services). EMLs are an important tool to inform health decisions at a country-level and at least 137 countries now have their own national EML. Despite this, there is wide variability in the methods used to develop them, and the certainty of evidence of medicines included on WHO’s MLEM and national EMLs. Additionally, a lack of coordination may result in time delays in updating EMLs or unnecessary duplication of efforts between EMLs and other evidence synthesis and health decision-making paradigms, such as health guidelines. In this thesis, we seek to understand the decision-making process for EMLs with particular focus on WHO’s MLEM, and to identify and advance opportunities to coordinate their development with health guidelines. This is accomplished through three papers, which build upon each other in this sandwich thesis. Paper 1 is a qualitative interview study with EML and guideline stakeholders to better understand decision-criteria and processes in EMLs. Paper 2 evaluates, using user-experience testing, a framework for the connection of guidelines and EMLs using an Evidence-to-Decision (EtD) framework for EMLs. Paper 3 presents a stakeholder-driven Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group concept paper exploring the conceptual challenges and opportunities of linking guidelines and EMLs using case studies on real-world implementation of this connection. / Thesis / Doctor of Philosophy (PhD) / Medicines are important for treating health conditions, and the most important medicines are called essential medicines. Essential Medicine Lists (EMLs) are created to determine what should be considered an essential medicine around the world, and also to ensure people have access to them. The number of medicines on the World Health Organization’s Model List of Essential Medicines (MLEM) has grown since it was first released, but these medicines aren’t always available to treat people who need them. Sometimes medicines that are not the most important are included on national essential medicine lists. The way that the WHO EML and national EMLs are made has been under review and criticized. Health guidelines tell people how medicines should be used, however, the connection between EMLs and health guidelines is not always consistent. Sometimes they may say different things about the same medicine. Additionally, there are differences in how EMLs and guidelines are established, and those involved do not always work with each other. In this thesis, I try to understand how decisions about which medicines are included in EMLs are made, and how they connect to health guidelines. Chapter 1 is an introduction to the topic. Chapter 2 asks experts about the decision-making process for EMLs. In chapter 3, we change a tool for guidelines to help connect guideline and EML decisions and ask for feedback regarding improvements. Chapter 4 presents the work with a group of guideline experts to present problems and suggest ways to overcome them to make EMLs and health guidelines better connected.

In Canada, less than half of the drugs that the World Health Organization classifies as Essential Medicines for the treatment of Neglected Diseases like Chagas disease, drug-resistant tuberculosis, echinococcosis, leishmaniasis, leprosy, malaria and sleeping sickness are formally available, even as collectively hundreds of patients require access to them each year. Essential Medicines, according to the WHO, are those “intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford”. Nevertheless, many of these Essential Medicines, like the conditions they treat, are neglected by pharmaceutical companies and governments alike in low-burden, high-income countries like Canada. The result is a reversal of the usual access to medicines narrative around novel, patented medicines unavailable in low-income countries; these are old, off-patent Essential Medicines, many of which have become widely available in low and middle-income countries yet increasingly difficult to access in many high-income countries. Their absence from countries like Canada is not due to their lack of medical utility – many of them are recognized domestically as the standard of care – but their lack of commercial value. Unfortunately, Canada’s regulatory system is premised upon keeping unsafe, ineffective or poor-quality drugs out, not bringing Essential Medicines in. As a result, these drugs must be accessed through ill-fitting mechanisms like Canada’s Special Access Programme (SAP). Other high-income countries face similar access challenges, though they may manifest in different ways; in the United States for instance, drugs that have disappeared from the Canadian market or simply never been introduced in the first place have instead had de facto monopolies unscrupulously exploited. In turn, as the COVID-19 pandemic has served to underscore, access to these Essential Medicines for Neglected Diseases is an issue that cannot be solved solely at the domestic level. Essential Medicines that threaten to disappear before the diseases they treat do also serve to highlight broader issues of domestic and international concern, from drug shortages to antimicrobial resistance. This thesis provides an in-depth exploration of the problem, and offers guidance on what Canada in particular can do about improving access to medicines, especially those for Neglected Diseases that have been largely absent from the Canadian pharmaceutical agenda.

This thesis explores how decentralisation of basic pharmaceutical assistance was introduced in Brazil. Decentralisation aimed to improve access to basic medicines. Nevertheless, the inconsistency in the availability of medicines in the Brazilian public health system (SUS - Unified Health System) justified the development of two seemingly contradictory, yet co-existing, approaches: decentralisation and recentralisation. The central question of my thesis was how the simultaneous processes of decentralisation and recentralisation, which took place between 1998 and 2011, have affected access to medicines distributed by SUS. My second aim was to explore how political and power dynamics impacted the implementation of decentralisation policies. I carried out semi-structured interviews with key actors in policy-making for pharmaceutical assistance; interviewees were selected from among the health secretaries and Ministry of Health officials that participated in interfederative boards of agreement. The Grounded Theory approach, as well as documentary analysis, informed my data collection and analysis. My findings suggest that decentralisation was important for improving the availability of medicines, although levels of improvement varied across the country. Decentralisation in itself was not sufficient to improve the availability of medicines largely due to the regional differences. Federative relationships involved in the decentralised management of pharmaceutical assistance are seen as important by health secretaries, but are considered laborious and time-consuming by Ministry of Health officials. Lack of compliance with agreements at state level was mentioned as one of the main barriers to further improving access to medicines. In this context of struggle, the Popular Pharmacy programme, controlled by the federal government, was created in 2004. The initiative, which can be regarded as a recentralisation process, rapidly improved the availability of basic medicines. There is no clear indication of which is the best approach for improving access to basic medicines in Brazil. Both decentralisation and centralisation worked well in some contexts but failed in others.

INTRODUÇÃO: Promulgadas em 2000 as Metas de Desenvolvimento do Milênio destacam-se internacionalmente como importante política de cooperação para o desenvolvimento. Resultado do empenho da Organização das Nações Unidas caracteriza-se como uma tentativa de diminuir as disparidades sociais e econômicas no início do século XXI. Constituída por oito Metas, com prazo final para cumprimento em 2015. O objetivo 8.E da oitava Meta é definido como a cooperação com a indústria farmacêutica e visa, proporcionar o acesso a medicamentos essenciais com preços acessíveis nos países em desenvolvimento. OBJETIVOS: descreveu-se por meio das recomendações dos Relatórios da ONU o progresso do Objetivo 8.E e as políticas públicas de saúde no Brasil, Cuba e México. METODOLOGIA O estudo caracterizou-se por um estudo de caso descritivo e exploratório realizado por meio do estudo das recomendações governamentais estabelecidas nos relatórios da ONU relativos ao Objetivo 8.E, no período de 2000 a 2012, de documentos oficiais dos três países estudados e de revisão de literatura sobre o assunto. RESULTADOS: verificou-se que as propostas estabelecidas nos Relatórios da ONU para garantia do acesso a medicamentos apresentaram-se como políticas públicas nacionais executadas por meio dos sistemas de saúde dos três países estudados antes da promulgação das Metas do Milênio. CONSIDERAÇÕES FINAIS: em âmbito internacional As Metas do Milênio apresentam importância na cooperação para o desenvolvimento internacional observou-se, contudo, que os sistemas de saúde, existentes nos países estudados, apresentaram papel fundamental na política de acesso a medicamentos essenciais e, decorrentemente, no cumprimento das recomendações estabelecidas para os Estados-membros do Objetivo 8.E de forma independente do financiamento e estratégias de cooperação internacional / INTRODUCTION : Enacted in 2000, the Millennium Development Goals stand out internationally as an important development cooperation policy . Resulting of the commitment of the United Nations they are characterized as an attempt to reduce social and economic disparities in the XXI century . Composed of eight goals , with deadline for compliance in 2015 . The Target 8.E of the eighth Goal is defined as in cooperation with the pharmaceutical industry to provide access to affordable essential drugs in developing countries . OBJECTIVES : describe by means of the recommendations of the UN reports progress on the Target 8.E and public health policies in Brazil , Cuba and Mexico. METHODOLOGY The study was characterized by a descriptive case study and exploratory study conducted by the governmental recommendations set out in the UN reports relating to Target 8.E in the period from 2000 to 2012 , the official documents of the three countries studied and literature review on the subject . RESULTS : we found that the proposals set out in UN reports for ensuring access to medicines presented as national public policies were implemented by health systems of the three countries studied prior to the enactment of the Millennium Goals . CONCLUSION : internationally, the Millennium Goals have importance in development cooperation, however was noted that the health systems in the countries studied , displayed major role in access to essential medicines and so forth in compliance with the recommendations established for the Member States of the Objective 8.E independently of international financing and international cooperation strategies

O aumento do consumo de medicamentos pela população idosa brasileira e mundial no século XXI, somado ao envelhecimento populacional e relevante transição epidemiológica, apontam para a necessidade de mais estudos epidemiológicos por serem úteis ao planejamento de intervenções em saúde no âmbito coletivo. Os Estudos de Utilização de Medicamentos representam uma importante estratégia nesse sentido, por permitir a obtenção de informações sobre padrões de prescrição e uso de medicamentos, representando, desta forma, etapa de grande importância das investigações epidemiológicas. Este estudo visa estimar a prevalência e caracterizar o perfil de utilização de medicamentos na população idosa atendida pelas farmácias básicas do município de Uberaba-MG, bem como identificar os fatores mais implicados no acesso a esses medicamentos. Tratou-se de um estudo transversal, pelo qual uma amostra casual de 384 usuários de medicamentos foi entrevistada após a retirada seus medicamentos nas farmácias básicas municipais, entre março e julho de 2015, sendo utilizado um instrumento de coleta de dados, previamente padronizado e aprovado pelo Comitê de Ética em Pesquisa da Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo (CEP-FCFRP-USP). O pesquisador coletou informações sociodemográficas e relativas à saúde dos indivíduos, fotocopiou as prescrições, perguntou sobre o acesso aos medicamentos, e aplicou os testes de Batalla (TB), Med-Take (MT), Morisky-Green (MG) e o Índice da Complexidade da Farmacoterapia (ICFT). A idade média foi de 68,8 anos, sendo 70,0% do sexo feminino, renda per capita média de R$ 862,7, com predomínio de pardos (44,0%), casados (58%), com ensino fundamental incompleto (43,15%); a morbidade de maior prevalência foi a Hipertensão Arterial Sistêmica (71,95%). Dos 384 participantes, 95 (24,7%) afirmaram não recorrer à farmácia básica mais próxima de sua residência e as principais justificativas foram: fácil acesso devido às linhas de ônibus (40%) e consulta na unidade (31,6%). O perfil farmacoepidemiológico apresentou um intervalo de um a dez fármacos utilizados por paciente, com média de três fármacos/paciente; a maior prevalência foi dos medicamentos do aparelho cardiovascular (40,9%); 55,5% realizam automedicação. Conhecimento satisfatório sobre a farmacoterapia foi observado em 49,7% dos participantes; os resultados dos testes TB e MG foram de 13% e 57% de aderentes à farmacoterapia, respectivamente, não havendo correlação linear entre os resultados destes testes. O valor médio do ICFT foi de 7,3, sendo que 32,8% dos participantes possuíam terapias de alta complexidade; este índice apresentou correlação linear negativa em relação ao teste MT. A polifarmácia (uso de seis ou mais princípios ativos) esteve presente em 25,5% dos idosos, a qual não apresentou associação estatística com as variáveis sexo, estado civil, idade, renda per capita e escolaridade. 570 interações medicamentosas potenciais foram verificadas, estando 47,4% dos participantes sujeitos a pelo menos uma interação; 54,7% utilizam medicamentos considerados inapropriados ao idoso. Tais evidências reforçam a necessidade da adoção de estratégias a fim de melhorar a farmacoterapia e a assistência prestada à saúde do paciente idoso. / The increased consumption of medicines by Brazilian elderly population and world in the twenty-first century, coupled with the aging population and relevant epidemiological transition point to the need for more epidemiological studies to be useful to health interventions planning in a community basis. The Drug Use Studies represent an important strategy accordingly, to allow obtaining information on patterns of prescription and use of drugs, representing thus step of great importance of epidemiological investigations. This study aims to estimate the prevalence and characterize the profile of use of drugs in the elderly population served by basic pharmacies in the city of Uberaba-MG, and identify more factors involved in access to these drugs. It was a cross-sectional study, whereby a random sample of 384 users of drugs was interviewed after that it was withdrawing its medicines on the basic pharmacies in the city, between March and July 2015, using a previously standardized and approved data collection instrument by Ethics Committee in Research of the Faculty of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo (CEP-FCFRP-USP). The researcher collected socio-demographic and health information from individuals, photocopied the prescriptions, asked about access to medicines, and applied the tests of Batalla (TB), Med-Take (MT), Morisky-Green (MG) and the Complexity Index of the Pharmacotherapy (ICFT). The average age was 68.8 years, 70.0% female, average per capita income of R$ 862.7, with a predominance of browns (44.0%), married (58%), with education incomplete elementary (43.15%); the most prevalent morbidity was Arterial Hypertension (71,95%). Of the 384 participants, 95 (24.7%) said they did not resort to basic pharmacy closest to your residence and the main reasons were: easy access due to bus lines (40%) and in consultation Unit (31.6%). The pharmacoepidemiological profile presented a range of one to ten drugs used per patient with average of three drugs/patient; the highest prevalence was among the drugs of the cardiovascular system (40.9%); 55.5% performed self-medication. Satisfactory knowledge on pharmacotherapy was observed in 49.7% of participants; the results of the TB and MG tests were 13% and 57% adherent to the pharmacotherapy, respectively, and there was no linear correlation between the results of these tests. The mean value of ICFT was 7.3, with 32.8% of participants having high complexity; this index presented a negative linear correlation in relation to the MT test. Polypharmacy (use of six or more active principles) was present in 25.5% of the elderly, which did not present statistic association with the variables gender, marital status, age, per capita income and schooling. 570 potential drug interactions were verified, with 47.4% of participants being subject to at least one interaction; 54.7% use drugs considered inappropriate to the elderly. Such evidences reinforce the need to adopt strategies to improve pharmacotherapy and health care for elderly patients.

Philosophiae Doctor - PhD / The concepts of availability, affordability, accessibility and acceptability otherwise known as the 4As of ATM are key factors that influence access to essential medicines in any given health system. However, the exact scale and extent to which these 4As affect various populations in Nigeria remains unknown. This study investigates the Nigerian healthcare system with special focus on access to quality and affordable essential medicines in three Nigerian States; Abuja, Kaduna and Nassarawa, by drawing upon primary data, using qualitative and quantitative research methods.

INTRODUÇÃO: Promulgadas em 2000 as Metas de Desenvolvimento do Milênio destacam-se internacionalmente como importante política de cooperação para o desenvolvimento. Resultado do empenho da Organização das Nações Unidas caracteriza-se como uma tentativa de diminuir as disparidades sociais e econômicas no início do século XXI. Constituída por oito Metas, com prazo final para cumprimento em 2015. O objetivo 8.E da oitava Meta é definido como a cooperação com a indústria farmacêutica e visa, proporcionar o acesso a medicamentos essenciais com preços acessíveis nos países em desenvolvimento. OBJETIVOS: descreveu-se por meio das recomendações dos Relatórios da ONU o progresso do Objetivo 8.E e as políticas públicas de saúde no Brasil, Cuba e México. METODOLOGIA O estudo caracterizou-se por um estudo de caso descritivo e exploratório realizado por meio do estudo das recomendações governamentais estabelecidas nos relatórios da ONU relativos ao Objetivo 8.E, no período de 2000 a 2012, de documentos oficiais dos três países estudados e de revisão de literatura sobre o assunto. RESULTADOS: verificou-se que as propostas estabelecidas nos Relatórios da ONU para garantia do acesso a medicamentos apresentaram-se como políticas públicas nacionais executadas por meio dos sistemas de saúde dos três países estudados antes da promulgação das Metas do Milênio. CONSIDERAÇÕES FINAIS: em âmbito internacional As Metas do Milênio apresentam importância na cooperação para o desenvolvimento internacional observou-se, contudo, que os sistemas de saúde, existentes nos países estudados, apresentaram papel fundamental na política de acesso a medicamentos essenciais e, decorrentemente, no cumprimento das recomendações estabelecidas para os Estados-membros do Objetivo 8.E de forma independente do financiamento e estratégias de cooperação internacional / INTRODUCTION : Enacted in 2000, the Millennium Development Goals stand out internationally as an important development cooperation policy . Resulting of the commitment of the United Nations they are characterized as an attempt to reduce social and economic disparities in the XXI century . Composed of eight goals , with deadline for compliance in 2015 . The Target 8.E of the eighth Goal is defined as in cooperation with the pharmaceutical industry to provide access to affordable essential drugs in developing countries . OBJECTIVES : describe by means of the recommendations of the UN reports progress on the Target 8.E and public health policies in Brazil , Cuba and Mexico. METHODOLOGY The study was characterized by a descriptive case study and exploratory study conducted by the governmental recommendations set out in the UN reports relating to Target 8.E in the period from 2000 to 2012 , the official documents of the three countries studied and literature review on the subject . RESULTS : we found that the proposals set out in UN reports for ensuring access to medicines presented as national public policies were implemented by health systems of the three countries studied prior to the enactment of the Millennium Goals . CONCLUSION : internationally, the Millennium Goals have importance in development cooperation, however was noted that the health systems in the countries studied , displayed major role in access to essential medicines and so forth in compliance with the recommendations established for the Member States of the Objective 8.E independently of international financing and international cooperation strategies

In the past several years, the impact of intellectual property rights (IPRs) on access to medicines and medical technologies has come under increased scrutiny. Motivating this are highly publicized cases where IPRs appear the threaten access to particular medicines and diagnostics. As IPRs become globalized, so does the controversy: In 1998, nearly forty pharmaceutical companies filed a lawsuit against South Africa, citing (among other issues) deprivation of intellectual property. This followed South Africa’s implementation of various measures to enable and encourage the use of generic medicines – a move that was particularly controversial for the newly available (and still patented) HIV medicines. While many historical, legal, economic, and policy analyses of these cases and issues exist, few explicitly normative projects have been undertaken. This thesis utilizes interdisciplinary and explicitly normative philosophical methods to fill this normative void, engaging theoretical work on intellectual property and global distributive justice with each other, and with empirical work on IPR reform. In doing so, it explicitly rejects three mistaken assumptions about the debate over IPRs and access to essential medicines: (i) that this debate reduces to a disagreement about empirical facts; (ii) that intellectual property is normatively justified solely by its ability to “maximize innovation”; and (iii) that this controversy reduces to irresolvable disagreement about global distributive justice. Calling upon the best contemporary approaches to human rights, it argues that these approaches lend normative weight in favor of reforming IPRs – both that they should be reformed, and how – to better enable access to essential medicines. Such reforms might include modifying the present global IPR regime or creating new alternatives to the exclusivity of IPRs, both of which are considered in light of a human right to access to essential medicines. Future work will be needed, however, to better specify the content of a right to “essential medicines” and determine a fair distribution of the costs of fulfilling it. / Dissertation

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