BACKGROUND Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which other provisions in trade agreements can affect pharmaceutical policy and, in turn, access to medicines have been little studied. There is a need for an analytical framework covering the full range of provisions, pathways, and potential impacts, on which to base future health and human rights impact assessment and research. A framework exploring the ways in which trade and investment agreements may affect pharmaceutical policy was developed, based on an analysis of four recently negotiated regional trade agreements. First a set of core pharmaceutical policy objectives based on international consensus was identified. A systematic comparative analysis of the publicly available legal texts of the four agreements was undertaken, and the potential impacts of the provisions in these agreements on the core pharmaceutical policy objectives were traced through an analysis of possible pathways. RESULTS An analytical framework is presented, linking ten types of provisions in the four trade agreements to potential impacts on four core pharmaceutical policy objectives (access and affordability; safety, efficacy, and quality; rational use of medicines; and local production capacity and health security) via various pathways. CONCLUSIONS The analytical framework highlights provisions in trade and investment agreements that need to be examined, pathways that should be explored, and potential impacts that should be taken into consideration with respect to pharmaceutical policy. This may serve as a useful checklist or template for health and human rights impact assessments and research on the implications of trade agreements for pharmaceuticals.

中文翻译：

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分析贸易和投资协定对药品政策的影响：规定，途径和潜在影响。

背景技术在世界贸易组织的《与贸易有关的知识产权协议》（TRIPS）之后谈判达成的贸易和投资协议，包括对知识产权的保护日益提高，以及影响药品政策许多方面的越来越多的规则。尽管有大量关于知识产权和可负担药品的获取的文献，但是贸易协定中其他条款可能影响药品政策以及反过来获取药品的方式却鲜有研究。有必要建立一个涵盖所有条款，途径和潜在影响的分析框架，以此为基础对未来的健康和人权影响进行评估和研究。在对最近谈判的四项区域贸易协定进行分析的基础上，制定了探索贸易和投资协定可能影响药品政策的方式的框架。首先，确定了基于国际共识的一套核心药物政策目标。对这四个协议的公开法律文本进行了系统的比较分析，并通过对可能途径的分析，追溯了这些协议中的条款对核心药品政策目标的潜在影响。结果提出了一个分析框架，将四个贸易协定中的十种规定与对四个核心药品政策目标（获取和可负担性；安全性，功效和质量；合理使用药物；以及合理使用）的潜在影响联系起来。以及本地生产能力和健康保障）。结论分析框架着重强调了需要审查的贸易和投资协定中的条款，应探索的途径以及与药品政策有关的潜在影响。这可以用作健康和人权影响评估以及研究贸易协定对药品的影响的有用清单或模板。