This project is at the controversial intersection of medicine patent protection and access to medicines at the international level. Advocates for medicine access argue that medicine patent protection may allow prices to become elevated, thereby frustrating medicine access. But advocates for medicine patent protection argue that the patent system incentivized the research and development to make the product possible in the first place. While this ideological debate is valuable, this doctoral project acknowledges the patent system’s existence and seeks to produce research to advance medicine access pragmatically within this context, especially in developing countries and especially for drugs appearing on the World Health Organization’s Model List of Essential Medicines (MLEM). In cooperation with the World Intellectual Property Organization, this project commenced with a legal study to assess the patent status of the entire MLEM (375 medicines) in 137 developing countries. Gathering these patent data and verifying them with global pharmaceutical suppliers was this project’s principal data collection. The patent data were further linked to development indicators of the countries implicated by our study and to economic data detailing medicine procurements made by those working with assistance from international organizations. Building upon the techniques refined during the MLEM study, three supplementary patent studies were performed to investigate very specific questions regarding medicine patenting and medicine access. With these patent data collected, we investigated companies’ medicine patent filing behaviours internationally. Various policy approaches to accelerating access at the international level were compared, including those that disregard patent protection and those are based on cooperation between medicine suppliers. Of the approaches considered, the cooperative approaches appeared to be the most efficient, especially voluntary licensing practices (i.e., originator companies license generic manufacturers to supply the product to developing countries in exchange for royalties). We find that while patents may detour generic competition at times, we also find they may serve as springboards for collaborative endeavours and global medicine access campaigns, like the one for HIV drugs. This thesis concludes by arguing that improved international medicine patent transparency by pharmaceutical suppliers is one of the most powerful ways to foster such collaborations to improve medicine access.

Decisions to reform pharmaceutical policy often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a reform that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only one order of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda for one year, has been exported. Future use of the regime appears unlikely. This research aimed to examine the politics underlying the formation of CAMR. Parliamentary committee hearing transcripts from CAMR's legislative development (2004) and from CAMR's legislative review (2007) were analyzed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analyzed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR's final policy design. In 2004, policy debates were dominated by two themes: intellectual property rights and TRIPS compliance. Promoting human rights and the impact of CAMR on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by a greater representation of the interests of potential beneficiary country governments. While the Government attempted to strike a balance between drug affordability and intellectual property protection, it designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.

Decisions to reform pharmaceutical policy often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a reform that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only one order of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda for one year, has been exported. Future use of the regime appears unlikely. This research aimed to examine the politics underlying the formation of CAMR. Parliamentary committee hearing transcripts from CAMR's legislative development (2004) and from CAMR's legislative review (2007) were analyzed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analyzed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR's final policy design. In 2004, policy debates were dominated by two themes: intellectual property rights and TRIPS compliance. Promoting human rights and the impact of CAMR on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by a greater representation of the interests of potential beneficiary country governments. While the Government attempted to strike a balance between drug affordability and intellectual property protection, it designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.

The health is considered a social right, should the state promote and ensure universal and equal access to its programs and services. Law No. 8,080 / 90 establishes that the National Health System (SUS) to perform integrated care stocks, including pharmaceutical, explaining the importance of access to medicines for complete assistance. Despite the creation of various programs and strategies, not always implemented pharmaceutical assistance meets the needs of the patient, allowing his claim through the courts. The city of Rio Largo has been obliged to comply with court orders to supply drugs since 2007. The proposal is to evaluate the profile of lawsuits filed to supply drugs Rio Largo city, Alagoas state. This is a cross-sectional study with quantitative approach. The primary data source was the lawsuit requesting drug filed by citizens against the Rio Largo city during the period 2007 to 2014. The variables were: demographic profile member of the plaintiff, procedural characteristics, medical and health and political- administrative lawsuits. It was observed that the most prevalent age range of participants was 60-69 years (15.1%) and 79.6% of the authors of the actions had 1 to 2 minimum wages and family income. In 95.7% of the shares were public legal representation and 100% of them preliminary injunction was granted for the supply of medicines. The profile of the diseases most commonly found in this study directly influenced the anatomical group of the most prevalent drugs, represented by the gastrointestinal tract and metabolism group (26.1%). Only 34.9% of judicialized drugs were prescribed by generic name, 18.1% were available in one or more of the lists of existing essential drugs, however, 83.0% had an alternative therapy in the SUS and 23.8% were suitable for off-label use. In 2014, spending on judicialized drugs were equivalent to more than a third of the total invested in Basic Pharmaceutical Assistance. You see the need for more technical support to the judiciary so that action can be brought against the appropriate body or it can be suggested evaluating the possibility of replacing the defendant drug on the other, available in SUS, avoiding waste of public resources. / A saúde é considerada um direito social, devendo o estado promover e garantir o acesso universal e igualitário as suas ações e serviços. A Lei nº 8.080/90 estabelece que o Sistema Único de Saúde (SUS) deve executar ações de assistência terapêutica integral, inclusive farmacêutica, explicitando a importância do acesso aos medicamentos para integralidade da assistência. Apesar da criação de vários programas e estratégias, nem sempre a assistência farmacêutica implementada atende às necessidades do paciente, possibilitando sua reivindicação por via judicial. O município de Rio Largo vem sendo obrigado a cumprir mandados judiciais para fornecimento de medicamentos desde 2007. A proposta é avaliar o perfil das demandas judiciais para fornecimento de medicamentos impetradas contra o município de Rio Largo, estado de Alagoas. Trata-se de um estudo transversal, com abordagem metodológica quantitativa. A fonte primária de dados foi o processo judicial solicitando medicamento impetrado por cidadão contra o município de Rio Largo durante o período de 2007 a 2014. As variáveis investigadas foram: perfil sócio demográfico do autor da ação, características processuais, médico-sanitárias e político-administrativas das ações judiciais. Observou-se que a faixa etária mais prevalente entre os participantes foi a de 60 a 69 anos (15,1%) e 79,6% dos autores das ações tinham de 1 a 2 salários mínimos como renda familiar. Em 95,7% das ações houve representação jurídica pública e em 100% delas foi concedida antecipação de tutela para fornecimento de medicamentos. O perfil das doenças mais encontradas neste estudo influenciou diretamente o grupo anatômico dos medicamentos mais prevalente, representado pelo grupo do trato alimentar e metabolismo (26,1%). Apenas 34,9% dos medicamentos judicializados foram prescritos pelo nome genérico, 18,1% estavam disponíveis em uma ou mais das listas de medicamentos essenciais vigentes, porém, 83,0% possuíam alternativa terapêutica no SUS e 23,8% foram indicados para uso off label. Em 2014, os gastos com medicamentos judicializados foram equivalentes a mais de um terço do total investido com Assistência Farmacêutica Básica. Percebe-se a necessidade de maior apoio técnico ao poder judiciário para que as ações possam ser impetradas contra a instância adequada ou para que possa ser sugerida a avaliação da possibilidade de substituição do fármaco demandado por outro, disponível no SUS, evitando-se o desperdício de recursos públicos.

Submitted by Luciana Ferreira (lucgeral@gmail.com) on 2016-10-03T13:23:24Z No. of bitstreams: 2 Dissertação - Sâmia Cristina Rodrigues Borges Aragão - 2015.pdf: 3374814 bytes, checksum: f4bc7c58a16e041e8274c3529234f038 (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) / Approved for entry into archive by Luciana Ferreira (lucgeral@gmail.com) on 2016-10-03T13:24:52Z (GMT) No. of bitstreams: 2 Dissertação - Sâmia Cristina Rodrigues Borges Aragão - 2015.pdf: 3374814 bytes, checksum: f4bc7c58a16e041e8274c3529234f038 (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) / Made available in DSpace on 2016-10-03T13:24:52Z (GMT). No. of bitstreams: 2 Dissertação - Sâmia Cristina Rodrigues Borges Aragão - 2015.pdf: 3374814 bytes, checksum: f4bc7c58a16e041e8274c3529234f038 (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) Previous issue date: 2015-10-21 / Medications readily available for the Brazilian population in the Unified Health System (SUS) is one of the health policies and programmes that meet the constitutional right of every Brazilian citizen. Lots of regulations have been created for medication distribution through Pharmaceutical Assistance (PA), however the user of the medication sometimes is confused and how obtain it. Describe the pathway and regulations for medication distribution through the public health policies in a city. Qualitative research held from December 2014 to January 2015, which focused on normative and explanatory documents for the public health system in Brazil in the city of Goiania in Goias state. An extensive bibliographic research has been carried out on this topic to fundament the analysis of the documents. The medication right is defined in the Brazilian’s constitution, legislation and regulatory acts for the private labour sector and public through co-payment as a means for medication access. In Goiania establishes the Pharmaceutical Assistance (PA) as it is for the Pharmacy and Therapeutics Committee (CFT), SMS Pharmacies, publicizing information related to drugs, health programmes such as “Farmácia Popular“ and the administrative access road through the Division of Assets Evaluation and non-Standardized Services (DABSNP) as a way to meet the demands of those users who have failed treatment through public policies. The medications available through the public policies are organized by REMUNE and the list of medications with high costs of Juarez Barbosa. The public health programmes “Farmácia Popular” and “Saúde Não Tem Preço“ are the ways of co-payment and free of charge. Medications not listed on REMUNE or unavailable to the user are available via administrative process to prevent lawsuit. Conclusion: The medication right is defined in the Brazilian’s constitution, and public policies with little or no influence of local city government. However, how to obtain it, the list of available medication, and the requirements is a local governmental duty. Therefore, the policies defined for such programmes can facilitate the understanding of the network comprising the Pharmaceutical Assistance (PA) in the Brazil’s Unified Health System (SUS). / O acesso a medicamentos no Sistema Único de Saúde (SUS) integra as ações de atenção à saúde como um direito dos brasileiros. As vias institucionalizadas de acesso ao medicamento surgem mediante uma diversidade de regulamentações relacionadas à operacionalização da Assistência Farmacêutica (AF) que muitas vezes incorre em “confusão” junto ao usuário, na busca pela efetivação deste direito. Esta dissertação objetiva descrever as vias institucionalizadas de acesso ao medicamento em uma cidade brasileira. A pesquisa documental constituiu-se de natureza descritiva realizada nos meses de dezembro/2014 a janeiro/ 2015. O objeto de estudo foram documentos de caráter legal, normativo e explicativo capazes de descrever as vias de acesso institucionalizadas pelas políticas públicas de saúde vigentes no Brasil, em nível de assistência ambulatorial, no município de GoiâniaGO. Destaca-se que o direito ao acesso ao medicamento foi positivado no texto constitucional, na legislação infraconstitucional e em atos regulatórios que definem as vias pública, privada e através de co-pagamento como formas de acesso aos medicamentos. Em Goiânia a AF se encontra normatizada a respeito da Comissão de Farmácia e Terapêutica (CFT), funcionamento das farmácias da Secretaria Municipal de Saúde (SMS), publicização de informações relacionadas a medicamentos, implementação da Farmácia Popular (FP) e a via administrativa de acesso através da Divisão de Avaliação de Bens e Serviços Não-Padronizados (DABSNP), como forma de atender a demanda daqueles usuários que não conseguiram tratamento através das políticas públicas. O fluxo de acesso em Goiânia indica que os medicamentos disponíveis no sistema público estão organizados por meio da Relação Municipal de Medicamentos Esssenciais (REMUME) e da Lista de medicamentos de Alto Custo-Juarez Barbosa (Componente Especializado). As vias por co-pagamento e gratuitos são disponibilizadas pelos programas FP e “Saúde Não Tem Preço” (SNTP) e suas respectivas listas. A via administrativa de acesso, para medicamentos não constantes na REMUME ou indisponível para o usuário, cumpre papel de evitar que a demanda gere processo judicial. Conclusão: O direito ao medicamento é basicamente definido pelas políticas nacionais sofrendo pouca influência local. Já o itinerário que cada cidadão terá que percorrer e os medicamentos disponíveis são definidos em nível municipal. Portanto, o fluxo de acesso elaborado pode facilitar a compreensão da intrincada rede que constitui a Assistência Farmacêutica no Brasil.

In this thesis, the aim is to address the persistent challenges posed by differing perspectives despite the establishment of the TRIPS agreement, which serves as a shared foundation for addressing legal and practical gaps among jurisdictions worldwide. The focus is on analyzing the Bolar exemptions within TRIPS Flexibilities for pharmaceutical patents in three specific regions: the Republic of Finland, the People's Republic of China (China), and the United States (the US). By employing a hierarchical approach that incorporates deductive theory, examination of legal cases, and literature review, this research aims to identify and resolve disparities between these jurisdictions. Both international law and national legal systems are scrutinized to ensure comparability across the three continents. Ultimately, the study presents a comprehensive assessment of the advantages and disadvantages associated with implementing Bolar provisions in each country, particularly in the context of facilitating access to vaccines during the COVID-19 pandemic.

A implementação de medicamentos genéricos no Brasil e de programas e políticas para garantir o acesso da população a medicamentos com qualidade, segurança e eficácia resultaram em mais de 3.800 medicamentos genéricos de 445 fármacos registrados na Agência Nacional de Vigilância Sanitária (ANVISA) desde 1999. Os medicamentos genéricos comprovaram a sua equivalência terapêutica e, portanto, intercambialidade com seus respectivos medicamentos de referência por meio de estudos de bioequivalência. Em 2014, a ANVISA estendeu a intercambialidade aos medicamentos similares, aumentando o número de medicamentos intercambiáveis para cada medicamento de referência. As normas para prescrição e dispensação permitem apenas a substituição de medicamento de referência por seu medicamento genérico ou similar intercambiável e vice-versa. Entretanto, o que se observa na prática é a substituição entre medicamentos genéricos e similares de um mesmo fármaco, tanto na rede privada onde os descontos chegam até 90% do preço estabelecido para a venda, como na rede pública, em função da disponibilidade dos medicamentos, visto que as compras públicas se baseiam no menor preço ofertado pelos fabricantes. Entretanto, a bioequivalência e a intercambialidade entre os medicamentos genéricos ou similares de um mesmo referência não pode ser garantida pois os mesmos não foram testados entre si. A ausência de bioequivalência entre medicamentos substituídos pode provocar ineficácia terapêutica ou aparecimento de eventos adversos ou até mesmo intoxicação em pacientes. Consequentemente, podem ocorrer desperdício, gastos com tratamento de eventos adversos, abandono do tratamento e adoção de segunda linha de tratamentos. Este trabalho avaliou a bioequivalência entre os medicamentos genéricos e similares de um mesmo medicamento de referência por meio do método de metanálise, empregando dados de estudos de bioequivalência realizados para o registro de medicamentos genéricos e similares na ANVISA. Foram incluídos na análise estudos de aciclovir, amoxicilina, cefalexina, doxazosina, fenitoína, fluoxetina, levofloxacino e quetiapina. Os resultados demonstraram a ausência de bioequivalência entre a maioria dos medicamentos genéricos e similares contendo o mesmo fármaco. os resultados comprovam que medicamentos genéricos e similares de mesmo fármaco não são obrigatoriamente intercambiáveis e a substituição, principalmente para aqueles usados no tratamento de doenças crônicas, podem trazer graves consequências clínicas. Esta preocupação é aumentada para os fármacos com estreita faixa terapêutica e aqueles com alta variabilidade no processo de absorção. A adoção de uma lista de medicamentos não substituíveis, a exemplo de outros países, e o investimento na divulgação de informações sobre intercambialidade de medicamentos, tanto para profissionais de saúde como para a população, podem contribuir para a redução da substituição entre medicamentos não intercambiáveis, a promoção do uso racional dos medicamentos, a redução de gastos com medicamentos e tratamento de eventos adversos e o aumento da adesão do paciente ao tratamento. / The implementation of generic drugs in Brazil, as well as programs and policies to ensure access to medicines with quality, safety and efficacy to the overall population, resulted in more than 3,800 generic drug products of 445 drugs registered in the National Health Surveillance Agency (ANVISA) since 1999. Generic drug products proved their therapeutic equivalence in bioequivalence studies and, therefore, the interchangeability with their respective reference drug product. In 2014, ANVISA expanded the interchangeability to similar drug products, increasing the number of interchangeable drug products for each reference drug product. Regulations for the prescription and dispensation of medicine only allow the substitution of a reference drug product for a generic or an interchangeable similar drug product or vice versa. However, in practice, it appears that there is a substitution between generic and similar drug products of a same reference drug product in private pharmacy chains - where discounts reach up to 90% of the selling price - as well as in public pharmacy, depending on the medicine availability, because public purchases are based on the lower price offered by the manufacturers. Nevertheless, the bioequivalence and interchangeability between generic and similar drug products of the same reference drug product cannot be guaranteed because they haven\'t been evaluated. Lack of bioequivalence between substituted drug products may result in therapeutic ineffectiveness or the occurrence of adverse events and even to patient intoxication. As a consequence, there might be waste, expenses due to adverse events treatment, no adherence to the treatment or the adoption of second-line treatment. This study evaluated the bioequivalence between generic and similar drugs of the same reference drug product through a meta-analysis, using data from bioequivalence studies carried out for the registration of generic and similar drug products at ANVISA. The drugs included in the study were acyclovir, amoxicillin, cephalexin, doxazosin, phenytoin, fluoxetine, levofloxacin and quetiapine. Results showed lack of bioequivalence between most of the generic and similar drugs containing the same drug and prove that generic and similar drug products of the reference drug product are not necessarily interchangeable. Moreover, the substitution of drugs used for chronic illnesses could lead to serious clinical consequences. This concern increases for drugs with narrow therapeutic index and those with high variable absorption process. The adoption of a list of non-interchangeable medicines - like in other countries - and investment in the dissemination of information about interchangeability between drug products to health professionals and to the population may contribute to reduce the substitution of drugs which are not interchangeable, promote a rational use of medicines, the reduction of expenses with drugs and adverse effects treatment and to improve treatment adherence.

Made available in DSpace on 2016-08-10T10:47:13Z (GMT). No. of bitstreams: 1 MARINA ZAVA DE FARIA NUNES.pdf: 891847 bytes, checksum: 721e7bfd66a50cac76da0f8e9086c684 (MD5) Previous issue date: 2014-06-30 / This work is linked to the research line "socio-economic relations", the Graduate Program in Law, International Relations and Development at the Catholic University of Goiás and analyzes the institution of compulsory licensing for drugs as a public health policy in the optics of the case analysis of "antiretroviral" Efavirenz. The dissertation discusses how problematic the apparent conflict between two fundamental rights when access to medicines through public health policies: the right to health and right to intellectual property. It points out, however, the relevance of the legal institution of compulsory or compulsory licensing as an instrument to achieve harmonization between the mentioned example of rights. Como defended, will be conducting a case study, aiming to demonstrate the consequence of compulsory licensing for the compound Efavirez Program against AIDS held in Brazil. As a theoretical framework dissertation includes a discussion of the social function of property, sung by Marques Medicine, collision and weighting of fundamental rights applied to the case in the teachings of Alexy, and finally the theory of fundamental rights Canotilho. / Este trabalho vincula-se à linha de pesquisa ―Relações sócio-economicas‖, do Programa de Pós-Graduação em Direito, Relações Internacionais e Desenvolvimento da Pontifícia Universidade Católica de Goiás e analisa o instituto de licença compulsória para medicamentos como política pública de saúde sob a ótica da análise de caso do ―anti-retroviral‖ Efavirenz. A dissertação aborda como problemática a aparente colisão entre dois direitos fundamentais quando do acesso a medicamentos através de políticas públicas de saúde: o direito à saúde e o direito à propriedade intelectual. Aponta-se, portanto, a relevância do instituto jurídico do licenciamento compulsório ou obrigatório como instrumento capaz de realizar a harmonização entre os mencionados direitos. Como exemplo do defendido, realizaremos um estudo de caso, buscando demonstrar as consequênicas do licenciamento obrigatório do composto Efavirez para o Programa de combate à AIDS realizado no Brasil. Como referencial teórico a dissertação abarca a discussão da função social da propriedade, entoada por Remédio Marques, a colisão e a ponderação de direitos fundamentais aplicados ao caso concreto nos ensinamentos de Alexy, e por fim a teoria dos direitos fundamentais de Canotilho.

Submitted by Nadir Basilio (nadirsb@uninove.br) on 2019-03-18T18:28:09Z No. of bitstreams: 1 Priscila Freitas Cirico.pdf: 2028681 bytes, checksum: 808a9035d350ba4717dd6adebf5a4010 (MD5) / Made available in DSpace on 2019-03-18T18:28:09Z (GMT). No. of bitstreams: 1 Priscila Freitas Cirico.pdf: 2028681 bytes, checksum: 808a9035d350ba4717dd6adebf5a4010 (MD5) Previous issue date: 2019-02-11 / In Brazil, the Constitution enacted in 1988 establishes that "health is a right of everyone and the duty of the State", and the Unified Health System (SUS) is based on the universal right to health, equal access, decentralization and participation of society. Even with the progress of the Unified Health System, there are still difficulties to guarantee the population's access to medicines and there are a large number of lawsuits for drug applications resulting in an impact on the financing of pharmaceutical assistance in the SUS. This study aims to analyze the results of the Access SUS Program, implemented in Grande São Paulo in the year 2017 with the main objective of conducting pharmaceutical and nutritional orientation, seeking the rational provision and reduction of legal actions to obtain medicines. This is a quantitative documentary research based on reports and presentations of results provided by the State Department of Health of São Paulo (SES / SP), with data coming from the service Programa Acessa SUS between February 2017 and July 2018 and of lawsuits served by SES-SP between January 2014 and August 2018. Data were analyzed using Microsoft® Excel Software for Windows 2016 using descriptive statistics. The results show that R $ 796,993,815.29 was spent with lawsuits between 2014 and 2018 and that in 2017 there was a 3% decrease in the number of lawsuits and a 5% decrease in legal expenses compared to 2016. In addition, we can consider that 34% of lawsuits for drug solicitation could have been avoided between the years 2014 and 2018 since they are drugs that are part of the SUS distribution list, which demonstrates the potential of the Programa Acessa SUS. / No Brasil, a Constituição promulgada em 1988 determina que “a saúde é um direito de todos e dever do Estado”, e o Sistema Único de Saúde (SUS) se fundamenta no direito universal a saúde, acesso igualitário, descentralização e participação da sociedade. Mesmo com os avanços do Sistema Único de Saúde, ainda existem dificuldades para garantir o acesso da população aos medicamentos e observa-se grande número de ações judiciais para solicitações de medicamentos resultando em impacto no financiamento da assistência farmacêutica no SUS. Esta pesquisa visa analisar os resultados do Programa Acessa SUS, implantado na Grande São Paulo no ano de 2017, com o objetivo principal de realizar orientação farmacêutica e nutricional, buscando o fornecimento racional e a diminuição das ações judiciais para obtenção de medicamentos. Trata-se de uma pesquisa documental quantitativa realizada a partir de relatórios e apresentações de resultados fornecidos pela Secretaria Estadual de Saúde de São Paulo (SES/SP), com dados provenientes do atendimento do Programa Acessa SUS entre fevereiro de 2017 e julho de 2018 e de demandas judiciais atendidas pela SES-SP entre janeiro de 2014 e agosto de 2018. Os dados foram analisados com o auxílio do Software Microsoft® Excel para Windows 2016 por meio da estatística descritiva. Os resultados demonstram que foram gastos R$ 796.993.815,29 com ações judiciais entre 2014 e 2018 e que em 2017 houve diminuição de 3% na quantidade de demandas e de 5% nos gastos com ações judiciais em comparação a 2016. Além disso, podemos considerar que 34% das ações judiciais para solicitação de medicamentos poderiam ter sido evitadas entre os anos de 2014 e 2018, visto que são medicamentos que fazem parte do elenco de distribuição do SUS, o que demonstra o potencial de atuação do Programa Acessa SUS.

A implementação de medicamentos genéricos no Brasil e de programas e políticas para garantir o acesso da população a medicamentos com qualidade, segurança e eficácia resultaram em mais de 3.800 medicamentos genéricos de 445 fármacos registrados na Agência Nacional de Vigilância Sanitária (ANVISA) desde 1999. Os medicamentos genéricos comprovaram a sua equivalência terapêutica e, portanto, intercambialidade com seus respectivos medicamentos de referência por meio de estudos de bioequivalência. Em 2014, a ANVISA estendeu a intercambialidade aos medicamentos similares, aumentando o número de medicamentos intercambiáveis para cada medicamento de referência. As normas para prescrição e dispensação permitem apenas a substituição de medicamento de referência por seu medicamento genérico ou similar intercambiável e vice-versa. Entretanto, o que se observa na prática é a substituição entre medicamentos genéricos e similares de um mesmo fármaco, tanto na rede privada onde os descontos chegam até 90% do preço estabelecido para a venda, como na rede pública, em função da disponibilidade dos medicamentos, visto que as compras públicas se baseiam no menor preço ofertado pelos fabricantes. Entretanto, a bioequivalência e a intercambialidade entre os medicamentos genéricos ou similares de um mesmo referência não pode ser garantida pois os mesmos não foram testados entre si. A ausência de bioequivalência entre medicamentos substituídos pode provocar ineficácia terapêutica ou aparecimento de eventos adversos ou até mesmo intoxicação em pacientes. Consequentemente, podem ocorrer desperdício, gastos com tratamento de eventos adversos, abandono do tratamento e adoção de segunda linha de tratamentos. Este trabalho avaliou a bioequivalência entre os medicamentos genéricos e similares de um mesmo medicamento de referência por meio do método de metanálise, empregando dados de estudos de bioequivalência realizados para o registro de medicamentos genéricos e similares na ANVISA. Foram incluídos na análise estudos de aciclovir, amoxicilina, cefalexina, doxazosina, fenitoína, fluoxetina, levofloxacino e quetiapina. Os resultados demonstraram a ausência de bioequivalência entre a maioria dos medicamentos genéricos e similares contendo o mesmo fármaco. os resultados comprovam que medicamentos genéricos e similares de mesmo fármaco não são obrigatoriamente intercambiáveis e a substituição, principalmente para aqueles usados no tratamento de doenças crônicas, podem trazer graves consequências clínicas. Esta preocupação é aumentada para os fármacos com estreita faixa terapêutica e aqueles com alta variabilidade no processo de absorção. A adoção de uma lista de medicamentos não substituíveis, a exemplo de outros países, e o investimento na divulgação de informações sobre intercambialidade de medicamentos, tanto para profissionais de saúde como para a população, podem contribuir para a redução da substituição entre medicamentos não intercambiáveis, a promoção do uso racional dos medicamentos, a redução de gastos com medicamentos e tratamento de eventos adversos e o aumento da adesão do paciente ao tratamento. / The implementation of generic drugs in Brazil, as well as programs and policies to ensure access to medicines with quality, safety and efficacy to the overall population, resulted in more than 3,800 generic drug products of 445 drugs registered in the National Health Surveillance Agency (ANVISA) since 1999. Generic drug products proved their therapeutic equivalence in bioequivalence studies and, therefore, the interchangeability with their respective reference drug product. In 2014, ANVISA expanded the interchangeability to similar drug products, increasing the number of interchangeable drug products for each reference drug product. Regulations for the prescription and dispensation of medicine only allow the substitution of a reference drug product for a generic or an interchangeable similar drug product or vice versa. However, in practice, it appears that there is a substitution between generic and similar drug products of a same reference drug product in private pharmacy chains - where discounts reach up to 90% of the selling price - as well as in public pharmacy, depending on the medicine availability, because public purchases are based on the lower price offered by the manufacturers. Nevertheless, the bioequivalence and interchangeability between generic and similar drug products of the same reference drug product cannot be guaranteed because they haven\'t been evaluated. Lack of bioequivalence between substituted drug products may result in therapeutic ineffectiveness or the occurrence of adverse events and even to patient intoxication. As a consequence, there might be waste, expenses due to adverse events treatment, no adherence to the treatment or the adoption of second-line treatment. This study evaluated the bioequivalence between generic and similar drugs of the same reference drug product through a meta-analysis, using data from bioequivalence studies carried out for the registration of generic and similar drug products at ANVISA. The drugs included in the study were acyclovir, amoxicillin, cephalexin, doxazosin, phenytoin, fluoxetine, levofloxacin and quetiapine. Results showed lack of bioequivalence between most of the generic and similar drugs containing the same drug and prove that generic and similar drug products of the reference drug product are not necessarily interchangeable. Moreover, the substitution of drugs used for chronic illnesses could lead to serious clinical consequences. This concern increases for drugs with narrow therapeutic index and those with high variable absorption process. The adoption of a list of non-interchangeable medicines - like in other countries - and investment in the dissemination of information about interchangeability between drug products to health professionals and to the population may contribute to reduce the substitution of drugs which are not interchangeable, promote a rational use of medicines, the reduction of expenses with drugs and adverse effects treatment and to improve treatment adherence.