TRIPS Agreement Flexibilities and Their Limitations: A Response to the UN Secretary-General's High-Level Panel Report on Access to Medicines
64 Pages Posted: 13 Jun 2017
Date Written: June 12, 2017
Members of the World Trade Organization (“WTO”) must establish minimum standards of patent protection that are consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), including for pharmaceutical products. In describing the “flexibilities” accorded pursuant to the TRIPS Agreement, however, the Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines (“HLP Report”) strays far from principles of treaty interpretation under the Vienna Convention on the Law of Treaties.
While the HLP Report correctly identifies and catalogues a number of flexibilities that are explicitly referenced in the patent provisions of the TRIPS Agreement — such as transitional periods for least developed countries or deference relating to patent exhaustion — the HLP Report finds other flexibilities that are derived only from an improper interpretation of the Agreement. Particularly problematic is the HLP Report’s encouragement of WTO Members to make use of a broad “freedom to determine” — for themselves — the meaning of substantive requirements of patentability in the interests of advancing short term access to existing medicines.
After describing the principles of treaty interpretation, the article outlines the patent-related TRIPS flexibilities and their limitations, including (i) ex ante flexibilities, relating to the initial grant of the patent, and (ii) ex post flexibilities, relating to the rights conferred to a patent owner. In doing so, the article highlights instances where the HLP Report inappropriately recommends and encourages WTO Members to disregard substantive requirements of the TRIPS Agreement. Finally, the article considers TRIPS-plus protections as an additional “flexibility” available to WTO Members.
Keywords: TRIPS, Patents, WTO, UN, Health
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