Unit 11 - Readings & Viewings

Read the TRIPS Agreement, paying particular attention to Article 31 (mandatory licensing provisions, in effect technology transfer) and Article 31-bis added as an amendment to enable third party countries to manufacture pharmaceuticals for a smaller developing countries typically without an indigenous pharmaceutical industry.  (So, for example, India or Brazil as larger developing nations with generic pharmaceutical industries might manufacture a retroviral drug needed by a small and poorer sub-Saharan developing country suffering an AIDs epidemic.)  Note that the third-party country manufacturing arrangement under Article 31 bis is limited to pharmaceuticals.

Concerning the AIDs retroviral drug licensing for sub-Saharan Africa as the familiar example:

a. Read concerning the background of the third party country manufacturing solution Jerome Reichman, “Compulsory licensing of patented pharmaceutical inventions:  evaluating the options,” 37 J Law Med Ethics 247 (2009).

b. The sub-Saharan African problems were not addressed just by mandatory IP licensing, and Big Pharma’s litigation strategy and pricing encountered significant criticism, such that they eventually abandoned a strategy that would have impacted their IP, see “Drug companies withdraw HIV law suit,” HIV Treatment Bulletin, 2001.

c. This is typically recognized in terms of broader public health challenges involved with sub-Saharan Africa continuing now 15-20 years later, see G. Taylor, “Rolling out HIV antiviral therapy in sub-Saharan Africa:  2003-2017,” 44 Canadian Communicable Disease Rep 68 (2018).

d. But TRIPs Article 31 is now probably better understood in the context of climate change and “green technology.”  How well will TRIPs work for propagation of green technology if Article 31-bis was intentionally limited to pharmaceuticals, but green technology presumably involves other technologies (for example, renewable energy and storage batteries)?  What have we learned?

Review TRIPS material on the WTO website, including TRIPS: Geographical Indications, and TRIPS, traditional knowledge, biodiversity. Because of the biodiversity link, TRIPS concerns now seemingly touch on environmental issues too.  The biodiversity link is a shorthand reference to the idea that under the 1992 Convention on Biodiversity (part of the 1992 Rio environmental agreements), countries have some interest in products derived from organisms attributed to them (e.g., Brazil could claim an inchoate interest in anti-cancer medicines derived from some fungus at home in the Amazon River Basin).  The traditional knowledge link is the idea that indigenous peoples often have used medicinal plants, etc., raising questions about whether medicines derived from such “traditional knowledge” should in the alternative be patentable (the novelty issue), or should involve some licensing claim for the traditional knowledge (but who owns “traditional knowledge”?).

Watch WTO Forum: Does the "TRIPS" agreement strike the right balance? (Celine Charveriat, Oxfam and Harvey Bale, International Federation of Pharmaceutical Manufacturers Association 7/16/07).