Pharmaceutical policies for gaining access to high-priced medicines: a comparative analysis between England and Brazil / Políticas farmacêuticas para acesso a medicamentos de alto preço: uma análise comparativa entre Inglaterra e Brasil

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.

RESUMO Embora o National Health Service (NHS) e o Sistema Único de Saúde (SUS) sejam sistemas com princípios universais semelhantes, diferentes políticas no campo farmacêutico podem coexistir. O objetivo deste artigo foi fornecer uma análise comparativa destacando estratégias para garantir o acesso e a sustentabilidade a Medicamentos de Alto Preço (MAP) no Brasil e na Inglaterra. Foi realizada uma revisão integrativa da literatura em bases de dados eletrônicas, complementada por literatura cinzenta pesquisada em plataformas governamentais (leis, decretos, portarias e resoluções). Um total de 47 artigos e 7 políticas foram selecionados e categorizadas para análise. Os resultados demostraram que ambos os países aplicam distintas políticas para garantir o acesso aos MAP, entre elas, políticas para definição de preço e reembolso e ações para regular a utilização destes medicamentos dentro do sistema. Além disso, os países aplicam políticas distintas à sua própria sustentabilidade como as parcerias para o desenvolvimento produtivo local no Brasil e acordos confidenciais com indústrias multinacionais na Inglaterra. Em conclusão, apesar das semelhanças nos princípios, estes países têm proposto e aplicado políticas farmacêuticas distintas para manter o acesso e a sustentabilidade de seus sistemas de saúde.

Decision-making in the midst of uncertainty: appraising expensive medicines in England.

Decisions need to be made about which services or technologies should be prioritized for provision in the NHS in England .The analysis focuses specifically on the National Institute for Health and Care Excellence (NICE), and on how they appraise expensive medicines. This analysis takes a sociological perspective on decision-making in relation to uncertainty and how uncertainties are managed, drawing on evidence from a scoping study and an ethnographic study. Uncertainties were central to these rationing decisions. Three types of layers of uncertainty -epistemic, procedural and interpersonal - were shown to be salient. Another form of uncertainty was associated with the complexity of the science and that included the level of technicality of the information provided. The analysis highlighted the salience of uncertainties associated with interpersonal relations and the relations between the committees and the drug industry, clinical and patient experts. A key element in these relationships was trust. Decision makers adopted a mixture of formal and informal, collective and individual strategies in making decisions and a need to exercise pragmatism within a more formal institutional framework. The paper concludes by considering more recent policy developments in relation to appraising expensive medicines.

Decision-making in the midst of uncertainty: appraising expensive medicines in England / Tomada de decisão em meio à incerteza: avaliando medicamentos de alto preço na Inglaterra

Abstract Decisions need to be made about which services or technologies should be prioritized for provision in the NHS in England .The analysis focuses specifically on the National Institute for Health and Care Excellence (NICE), and on how they appraise expensive medicines. This analysis takes a sociological perspective on decision-making in relation to uncertainty and how uncertainties are managed, drawing on evidence from a scoping study and an ethnographic study. Uncertainties were central to these rationing decisions. Three types of layers of uncertainty -epistemic, procedural and interpersonal - were shown to be salient. Another form of uncertainty was associated with the complexity of the science and that included the level of technicality of the information provided. The analysis highlighted the salience of uncertainties associated with interpersonal relations and the relations between the committees and the drug industry, clinical and patient experts. A key element in these relationships was trust. Decision makers adopted a mixture of formal and informal, collective and individual strategies in making decisions and a need to exercise pragmatism within a more formal institutional framework. The paper concludes by considering more recent policy developments in relation to appraising expensive medicines.

Resumo O Serviço Nacional de Saúde Inglês precisa tomar decisões sobre quais serviços ou tecnologias devem ser priorizados. A análise se concentra no Instituto Nacional de Excelência em Saúde e Cuidados (NICE) e em como avalia medicamentos de alto preço. Essa análise adota uma perspectiva sociológica na tomada de decisões em relação à incerteza e como elas são gerenciadas, com base em um estudo etnográfico e um estudo de escopo. As incertezas foram centrais para essas decisões. Três tipos de camadas de incerteza - sistêmica, processual e interpessoal - mostraram-se salientes. Outra forma de incerteza estava associada à complexidade da ciência e que incluía o nível de tecnicidade das informações fornecidas. A análise enfatizou particularmente a importância das incertezas associadas às relações interpessoais e às relações entre os comitês e os fabricantes de medicamentos, especialistas clínicos e de pacientes. Um elemento-chave nesses relacionamentos foi a confiança. Os tomadores de decisão adotaram uma mistura de estratégias formais e informais, coletivas e individuais na tomada de decisões e a necessidade de exercer o pragmatismo dentro de uma estrutura institucional formal. O texto finaliza considerando o desenvolvimento mais recente de políticas relacionadas à avaliação de medicamentos caros.