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Background The current organization of the pharmaceutical innovation system poses three major challenges for rare disease patients in terms of availability, accessibility and affordability of treatments. While some changes have emerged in the European Union to address some of these challenges, their impacts are not experienced uniformly across member states nor around the world. We have observed niche initiatives that are actively working to address those challenges within their local contexts. In a position paper in this journal, we characterized such initiatives as “social pharmaceutical innovation” (or SPIN): novel collaborations involving diverse sets of actors that break with conventional pharmaceutical innovation practices to develop interventions that address unmet societal needs of rare disease patients and that are not primarily market driven. Results Here we report on 15 cases of SPIN across Brazil, Canada, France and the Netherlands that we studied through semi-structured qualitative interviews ( n  = 151) with players involved in those cases. Our findings show how SPIN initiatives are reconfiguring pharmaceutical innovation networks to include a wider range of actors in redistributed and differentiated roles within innovation processes. Further, we find that SPINs are associated with changes in the ways data is gathered (often in clinical contexts rather than in conventional trials), and how evidence is assembled to improve access to the treatments. Finally, we demonstrate how SPINs are providing new routes for patients to access treatments for rare diseases, often at more affordable prices. Conclusions While promising, SPINs are not perfect solutions for rare disease patients or the broader challenges to the pharmaceutical innovation system. SPINs are specific solutions adapted to the particulars of local framing, institutions, national policy and care contexts of rare diseases, and should be developed as such. Our findings support these recommendations for SPIN: use local knowledge and expertise in crafting SPINs; develop comprehensive strategies for data governance, access and ownership; and explore new economic models to recoup investments and/or sustain future initiatives. We invite collaboration on these topics and emerging SPIN initiatives so as to support efforts at addressing challenges of availability, accessibility and affordability of treatments for rare diseases patients.

Rare diseases are associated with difficulties in addressing unmet medical needs, lack of access to treatment, high prices, evidentiary mismatch, equity, etc. While challenges facing the development of drugs for rare diseases are experienced differently globally (i.e., higher vs. lower and middle income countries), many are also expressed transnationally, which suggests systemic issues. Pharmaceutical innovation is highly regulated and institutionalized, leading to firmly established innovation pathways. While deviating from these innovation pathways is difficult, we take the position that doing so is of critical importance. The reason is that the current model of pharmaceutical innovation alone will not deliver the quantity of products needed to address the unmet needs faced by rare disease patients, nor at a price point that is sustainable for healthcare systems. In light of the problems in rare diseases, we hold that re-thinking innovation is crucial and more room should be provided for alternative innovation pathways. We already observe a significant number and variety of new types of initiatives in the rare diseases field that propose or use alternative pharmaceutical innovation pathways which have in common that they involve a diverse set of societal stakeholders, explicitly address a higher societal goal, or both. Our position is that principles of social innovation can be drawn on in the framing and articulation of such alternative pathways, which we term here social pharmaceutical innovation (SPIN), and that it should be given more room for development. As an interdisciplinary research team in the social sciences, public health and law, the cases of SPIN we investigate are spread transnationally, and include higher income as well as middle income countries. We do this to develop a better understanding of the social pharmaceutical innovation field’s breadth and to advance changes ranging from the bedside to system levels. We seek collaborations with those working in such projects (e.g., patients and patient organisations, researchers in rare diseases, industry, and policy makers). We aim to add comparative and evaluative value to social pharmaceutical innovation, and we seek to ignite further interest in these initiatives, thereby actively contributing to them as a part of our work.

This study aims to analyze the judicialization of health in Brazil and Colombia in light of the new Latin American Constitutionalism (NLC), a conceptual framework adopted in the region that breaks with the European and North American classic constitutional models. In Brazil, the Constitution of 1988 came as a response to a long period of military governments, and in Colombia the Constitution of 1991 emerged in a context of human rights abuses and high level of violence. TheNLC is materialized from these new political letters and based on increasing forms of participation and expansion of the role of the Judiciary and people's rights, including health. However, the constitutions that brought a broad bill of rights have failed to face market-oriented policies and privatization of health services, thus limiting the realization of the right to health to increasing litigation. In this scenario, the role of the Judiciary, which has been strengthened by the new constitutions, gained importance as the branch capable of realizing a provided but precluded right. The identification of health needs and claims by social segments is presented as a basic principle in this process and indicates the rescue of the NLC for the realization of the right to health through structural litigation.

This article analyzes intersectorial health-related policies (IHRP) based on a case study performed in 2008-2009 that mapped the social policies of the city of Piracicaba, State of Sao Paulo, Brazil. The research strategy comprised quantitative and qualitative methodologies and converging information sources. Legal and theoretical conceptual frameworks were applied to the Piracicaba study results and served as the basis for proposing a typology of IHRP. Three types of IHRP were identified: health policies where the health sector is coordinator but needs non-health sectors to succeed; policies with a sector other than health as coordinator, but which needs health sector collaboration to succeed; and thirdly, genuine intersectorial policies, not led by any one sector but by a specifically-appointed intersectorial coordinator. The authors contend that political commitment of local authorities alone may not be enough to promote efficient intersectorial social policies. Comprehension of different types of IHRP and their interface mechanisms may contribute to greater efficiency and coverage of social policies that affect health equity and its social determinants positively. In the final analysis,, this will lead to more equitable health outcomes. Este artigo analisa as Políticas Intersetoriais Relacionadas à Saúde (PIRS), com base em um estudo de caso realizado em 2008 e 2009 que mapeou as políticas sociais do município de Piracicaba, São Paulo, Brasil. A estratégia de pesquisa compreendeu metodologias qualitativa e quantitativa. Marcos legais e teóricos foram aplicados aos resultados do estudo de Piracicaba, servindo de base para a proposição de três tipos de PIRS: políticas de saúde coordenadas pelo setor saúde e que necessitam de outros para serem bem sucedidas; políticas coordenadas por outro setor, diferente do da saúde, mas que necessitam da participação deste para serem efetivas; e as políticas intersetoriais genuínas, que não são lideradas por um único setor mas sim por um órgão intersetorial criado especificamente para sua coordenação. Os autores sustentam que somente a vontade política do gestor pode não ser suficiente para a promoção de políticas intersetoriais eficientes, e que a compreensão dos tipos de PIRS, e seus diferentes mecanismos de articulação, podem contribuir para o aprimoramento e a cobertura das políticas sociais que afetam positivamente a equidade em saúde e os determinantes sociais. No final, isto irá conduzir a resultados com maior equidade em saúde.

For the sake of ideology, hundreds of thousands of avoidable deaths occurred, write Deisy Ventura and colleagues

Abstract In Brazil, health is considered a right of all and a duty of the State, and health workforce regulation is essential to ensure the safety, quality and effectiveness of the health services provided, which require professionals with skills, abilities and attitudes consistent with the service in question, as well as to guarantee dignified working conditions for health professionals and patients. This essay is a critical and up-to-date analysis of the main characteristics of Brazil’s health workforce regulation model. We first describe how the health workforce regulation is structured, addressing topics such as the regulatory autonomy of Professional Councils, the regulation of new healthcare professions and the judicialization of conflicts in the field. We then analyze the regulation of health higher education and the leading role of the Ministry of Education in this regulatory field. The present reflections point out possible ways to improve Brazil’s health workforce regulation model, having the consolidation of the Brazilian National Health System (SUS) and the full implementation of the right to health as guides. Resumo No Brasil, a saúde é considerada direito de todos e dever do Estado. A regulação do trabalho em saúde é atividade essencial para garantir a segurança, qualidade e eficácia dos serviços de saúde prestados, que exigem profissionais com competências, habilidades e atitudes condizentes. O trabalho em saúde deve ainda ser exercido com condições de trabalho dignas aos profissionais de saúde e aos pacientes. Este ensaio apresenta uma análise crítica e atual das principais características do modelo de regulação do trabalho em saúde no Brasil. O texto descreve, inicialmente, de que forma está estruturada a regulação do exercício profissional na área da saúde, abordando temas como a autonomia regulatória dos Conselhos Profissionais, a regulação de novas profissões de saúde e a judicialização dos conflitos regulatórios. Finalmente, são analisadas as características da regulação da formação de nível superior na área da saúde e o papel protagonista do Ministério da Educação nesse campo regulatório. As reflexões aqui apresentadas objetivam apontar possíveis caminhos para o aperfeiçoamento do modelo de regulação do trabalho em saúde no Brasil, tendo como norte a consolidação do Sistema Único de Saúde (SUS) e a plena efetivação do direito à saúde no Brasil.

Resumo No Brasil, a saúde é considerada direito de todos e dever do Estado. A regulação do trabalho em saúde é atividade essencial para garantir a segurança, qualidade e eficácia dos serviços de saúde prestados, que exigem profissionais com competências, habilidades e atitudes condizentes. O trabalho em saúde deve ainda ser exercido com condições de trabalho dignas aos profissionais de saúde e aos pacientes. Este ensaio apresenta uma análise crítica e atual das principais características do modelo de regulação do trabalho em saúde no Brasil. O texto descreve, inicialmente, de que forma está estruturada a regulação do exercício profissional na área da saúde, abordando temas como a autonomia regulatória dos Conselhos Profissionais, a regulação de novas profissões de saúde e a judicialização dos conflitos regulatórios. Finalmente, são analisadas as características da regulação da formação de nível superior na área da saúde e o papel protagonista do Ministério da Educação nesse campo regulatório. As reflexões aqui apresentadas objetivam apontar possíveis caminhos para o aperfeiçoamento do modelo de regulação do trabalho em saúde no Brasil, tendo como norte a consolidação do Sistema Único de Saúde (SUS) e a plena efetivação do direito à saúde no Brasil. Abstract In Brazil, health is considered a right of all and a duty of the State, and health workforce regulation is essential to ensure the safety, quality and effectiveness of the health services provided, which require professionals with skills, abilities and attitudes consistent with the service in question, as well as to guarantee dignified working conditions for health professionals and patients. This essay is a critical and up-to-date analysis of the main characteristics of Brazil’s health workforce regulation model. We first describe how the health workforce regulation is structured, addressing topics such as the regulatory autonomy of Professional Councils, the regulation of new healthcare professions and the judicialization of conflicts in the field. We then analyze the regulation of health higher education and the leading role of the Ministry of Education in this regulatory field. The present reflections point out possible ways to improve Brazil’s health workforce regulation model, having the consolidation of the Brazilian National Health System (SUS) and the full implementation of the right to health as guides.

Resumo Este artigo analisa as condições de acesso do imigrante boliviano ao sistema de saúde brasileiro e a percepção do direito à saúde. É um estudo transversal de metodologia quantitativa e qualitativa, realizado de 2013 a 2015. Foi elaborado um questionário com perguntas fechadas respondidas por 633 bolivianos, e em relação ao acesso à saúde por 472 indivíduos bolivianos maiores de 18 anos. A abordagem qualitativa foi feita por meio da análise de conteúdo de entrevistas semiestruturadas com 55 sujeitos (bolivianos, profissionais de saúde, representantes de Secretarias de Saúde, Consulado da Bolívia, Defensoria Pública da União, Ministério Público Federal e Organizações Não Governamentais). Os bolivianos conhecem o Sistema Único de Saúde (SUS) e utilizam com frequência a Atenção Primária à Saúde (APS). Todavia, barreiras de acesso são descritas, como falta de documentação, condições de trabalho, procedimentos de média e/ou alta complexidades, dificuldades para entenderem o que é dito assim como para serem compreendidos, entre outras. Sobressai-se a obtenção do Cartão Nacional de Saúde (CNS) como porta de entrada para o acesso à saúde, desempenhando papel de integração social. O reconhecimento da Saúde como direito social destaca-se entre os entrevistados, apontado como valor humano e solidário. A garantia desse reconhecimento fica ameaçada quando não se apoia na consolidação de políticas sociais que visem o fortalecimento da proteção social universal. Abstract This paper analyzes the health care accessibility conditions afforded to Bolivian immigrants in the Brazilian health system and their perception of the right to health. This was a cross-sectional, quantitative and qualitative study carried out from 2013 to 2015. Data were collected by a questionnaire with closed questions answered by 633 Bolivian individuals; questions regarding access to health were answered by 472 immigrants over 18 years old. Semi-structured interviews conducted with 55 subjects (Bolivians, health professionals, representatives of Health Departments, Consulate of Bolivia, Public Defender’s Office, Federal Public Prosecutor’s Office and Non-Governmental Organizations) underwent content analysis. Most Bolivian immigrants know the Brazilian National Health System (SUS) and often use Primary Health Care; however, they described structural and systemic barriers to health accessibility, such as lack of documentation, working conditions, medium and high complexity procedures, language barriers, among others. The National Health Card (CNS) is an important gateway to access health care, playing a role of social integration. Interviewees recognize health as a social right, pointing it out as a human and solidary value. Ensuring this recognition, when not based on the consolidation of social policies aimed at strengthening universal social protection, is threatened.