The trends and constructive ambiguity in international agreements on intellectual property and pharmaceutical affairs: Implications for domestic legislations in low- and middle-income countries.

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.