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ABSTRACT Although the National Health Service (NHS) and the Unified Health System (SUS) are systems with similar universal principles, they can show different political measure patterns in the pharmaceutical field. This paper aimed to provide a comparative analysis of pharmaceutical policies highlighting strategies to guarantee access and sustainability to High-Price Medicines (HPMs) in Brazil and England. We performed an integrative literature review in electronic databases, supplemented by grey literature searched on governmental platforms (laws, decrees, ordinances, and resolutions). A total of Forty-seven articles and seven policies were selected and categorized for analysis. The results showed that both countries apply distinct policies to ensure access to HPMs, among them, policies to define price and reimbursement and actions to regulate the use inside the system. Also, these countries apply distinct policies to their sustainability as local partnerships for product development in Brazil and confidential managed agreements with multinational industries in the England. In conclusion, despite similarities in principles, these countries have been proposing and applying distinct pharmaceutical policies to maintain access and ensure the sustainability of their health systems.

Introduction: To train pharmacists working in the public health system, the Brazilian Ministry of Health developed a specialization course called Pharmaceutical Service and Access to Medicine Management (PSAMM) between 2010 and 2016. The course was free of charge and used e-learning as its main approach. In the end, 2,500 pharmacists were trained. The purpose of this study was to identify and analyze the strengths, weaknesses, opportunities, and threats of an in-service and e-learning course for pharmacists working in a public health system. Materials and Methods: Three workshops involving 67 participants were conducted at the conclusion of the course to analyze the perspective of the PSAMM course's faculty (tutors, regional coordinators, professors, and management committee) and students (pharmacists). Strengths, weaknesses, opportunities, and threats analysis and qualitative analysis methods were used. Results and Discussion: The strength dimension had the greatest number of items. The qualitative analysis resulted in six categories: the category "E-learning in continuing education" had the most cited items. Internal elements such as in-service hands-on activities directly related to the professionals' roles, course contents, faculty, and the methods to offer the course (the mixed methods and materials) were positively assessed. Nonetheless, external elements were considered critical for the course's outcomes such as investments in the infrastructure of pharmaceutical services, access to the internet, local managers' support for continuing education and innovation implementation, practice of interprofessional collaboration, and political stability. The continuing education course in the public health system was affected by internal elements such as its project and structure as well as external elements such as the sociopolitical scenario. Continuing education investment must be accompanied by infrastructure investment and coordination of services.

The production of medicines with quality, safety and efficacy is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role in which the public health industrial complex is inserted, compliance with Good Manufacturing Practices (GMP) of the World Health Organization (WHO) is essential to export its drugs via international organizations. The objectives of this article were to identify the main technical requirements recommended by WHO and enforced by the Brazilian Health Regulatory Agency (Anvisa), for compliance and recognition of GMP for medicinal products, and to compare them critically, to obtain the prequalification of medicines. This literature and documentary review promoted a comprehensive approach on national regulations and WHO guidelines. This work enabled to show a high degree of harmonization concerning the topics/subtopics compared between WHO and the national standards guides imposed by Anvisa about GMP, which demonstrates an integration of the national legislation in the international context, corroborating the alignment between Anvisa and WHO regarding compliance with GMP. ; A produção de medicamentos com qualidade, segurança e eficácia é fundamental para atender às demandas nacionais e internacionais, com o fito de subsidiar a assistência farmacêutica no âmbito da saúde pública. Diante do papel estratégico em que o complexo fabril público de saúde está inserido, o cumprimento das Boas Práticas de Fabricação (BPF) da Organização Mundial de Saúde (OMS) é essencial para a exportação de seus medicamentos via organismos internacionais. Os objetivos deste artigo foram identificar os principais requisitos técnicos recomendados pela OMS e exigidos pela Agência Nacional de Vigilância Sanitária (Anvisa), para o cumprimento e reconhecimento das BPF de medicamentos, e compará-los, de maneira crítica, em prol da obtenção da pré-qualificação de medicamentos. A metodologia empregada promoveu uma abordagem abrangente acerca das regulamentações nacionais e dos guias da OMS, por intermédio da seguinte técnica de coleta de dados: pesquisa bibliográfica e documental. O presente trabalho possibilitou evidenciar um alto grau de harmonização acerca dos tópicos/subtópicos comparados entre os guias da OMS e a normatização nacional imposta pela Anvisa em BPF, o que demonstra uma inserção da legislação nacional no contexto internacional, corroborando o alinhamento entre a Anvisa e OMS, no tocante ao cumprimento das BPF.