Ribeiro Alane Andrelino, Acosta Angela, Pontes Marcela Amaral, Machado Beltran Manuel Alejandro, Peixoto Rafaela Tavares, Leite Silvana Nair
Faculty of Health Sciences, University of Brasilia, Brasilia, Brazil.
Departamento de Ciencias Farmacéuticas, Facultad de Ciencias Naturales, Universidad ICESI, Cali, Colombia.
Front Pharmacol. 2023 Jan 5;13:1063300. doi: 10.3389/fphar.2022.1063300. eCollection 2022.
The transparency of data on the value chain of medicines is crucial for the study and monitoring of the pharmaceutical system. These data may impact medicine pricing negotiations, contribute to patient access to pharmaceutical products, and strengthen health systems. This study analyzed the national strategies to ensure the transparency of data from medicine cost development to marketing in Argentina, Brazil, and Colombia. A descriptive study was carried out by searching databases, reports, documents, and scientific articles published between January and August 2022 related to rules on transparency and databases, including 1) marketing authorization; 2) pricing; 3) intellectual property; 4) clinical trials; 5) research and development (R&D); and 6) health technology assessment (HTA) of selected biopharmaceuticals. Transparency data, rules, and information are not uniform. The infostructures (organizational capacity for collecting and distributing information) regarding the pharmaceutical value chain in these three countries face limitations in appropriate measures to publicly share data and evidence, including pre-clinical data, clinical data, and costs. None of the countries require transparency about data on research and development costs. All three countries present similar publicization of data on marketing authorization and intellectual property, with some differences. The significant limitations in Argentina include the absence of formal price regulation and data on the volume of medicine purchased and respective amounts paid. Among the three countries, Brazil showed a higher degree of information transparency, perhaps due to the legal regulation that guarantees citizens access to information of public interest. Brazil also stands out in terms of the public availability of HTA reports and pricing, in addition to the highest volume of information. In contrast, Colombia has in place a decree that allows 5 years of trial data exclusivity for new medicines, an act contrary to data transparency. Despite the different stages of transparency, no country has evidenced a robust use of these data in public policy decision-making. The results reinforce the presence of information asymmetry between stakeholders, data fragmentation, data gaps and overlap, and difficulty in comparing available data across the three countries and the use of these data nationally to produce evidence.
药品价值链数据的透明度对于药品系统的研究和监测至关重要。这些数据可能会影响药品定价谈判，有助于患者获得药品，并加强卫生系统。本研究分析了阿根廷、巴西和哥伦比亚确保从药品成本开发到营销的数据透明度的国家战略。通过搜索2022年1月至8月期间发表的与透明度规则和数据库相关的数据库、报告、文件和科学文章，开展了一项描述性研究，包括1）营销授权；2）定价；3）知识产权；4）临床试验；5）研发；以及6）选定生物制药的卫生技术评估。透明度数据、规则和信息并不统一。这三个国家药品价值链的信息结构（收集和分发信息的组织能力）在公开共享数据和证据（包括临床前数据、临床数据和成本）的适当措施方面面临限制。没有一个国家要求研发成本数据透明。所有三个国家在营销授权和知识产权数据的公开方面都有相似之处，但也存在一些差异。阿根廷的重大限制包括缺乏正式的价格监管以及药品采购量和支付金额的数据。在这三个国家中，巴西的信息透明度较高，这可能归功于保障公民获取公共利益信息的法律法规。除了信息量最大之外，巴西在卫生技术评估报告和定价的公开可得性方面也很突出。相比之下，哥伦比亚有一项法令允许新药有5年的试验数据独占期，这一行为与数据透明度相悖。尽管透明度处于不同阶段，但没有一个国家证明在公共政策决策中有力地使用了这些数据。研究结果进一步证明了利益相关者之间存在信息不对称、数据碎片化、数据缺口和重叠，以及在这三个国家之间比较现有数据和在国内使用这些数据以提供证据存在困难。
