a Institute of Health and Environment , Seoul National University , Seoul , South Korea.
b Department of Public Health Science, Graduate School of Public Health , Seoul National University , Seoul , South Korea.
Glob Public Health. 2018 Sep;13(9):1169-1178. doi: 10.1080/17441692.2017.1334807. Epub 2017 Jun 6.
The purpose of this study is to analyse the trends in international agreements including Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Korea-United States Free Trade Agreements, and Trans-Pacific Partnership Agreements on intellectual property and pharmaceutical affairs with the updated framework. The study also assesses constructive ambiguity in international agreements, which might affect the implementation process through interpretation and domestic legislations. Five flexibility clauses and three TRIPS-plus provisions were selected, and presence of constructive ambiguity in the agreements was analysed to draw actual trends in international agreements. Flexibility provisions excluding compulsory licensing were not noticeably changed, and TRIPS-plus provisions including data exclusivity and patent linkage were expanded in scope or newly appeared, respectively. The clause regarding compulsory licensing, extension of the patent term, data exclusivity, and patent linkage showed unclear definitions or the lack of adequate explanations. With constructive ambiguity in those clauses, a country who wants to join international agreements in the near future could amend domestic legislations to minimise the detrimental effect of international agreements on access to medicines.
本研究旨在分析包括《与贸易有关的知识产权协定》（TRIPS 协定）、《韩美自由贸易协定》和《跨太平洋伙伴关系协定》在内的国际协议中知识产权和药品事务的趋势，并采用更新的框架。本研究还评估了国际协议中的建设性模糊性，这种模糊性可能会通过解释和国内立法影响实施过程。选择了五个灵活性条款和三个 TRIPS-plus 条款，并分析了协议中的建设性模糊性，以得出国际协议中的实际趋势。不包括强制许可的灵活性条款没有明显变化，而包括数据独占和专利链接的 TRIPS-plus 条款的范围分别扩大或新出现。关于强制许可、专利期限延长、数据独占和专利链接的条款定义不明确或缺乏充分解释。由于这些条款存在建设性模糊性，因此，一个国家如果希望在不久的将来加入国际协议，可以修改国内立法，将国际协议对药品获取的不利影响降至最低。
